A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
Study Details
Study Description
Brief Summary
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by SAGE-217 for 4 days.
Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Drug: SAGE-217
Drug: Levodopa
Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
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Experimental: Part B: Antiparkinsonian Agent(s) + SAGE-217 Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Drug: SAGE-217
Drug: Antiparkinsonian Agent(s)
Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
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Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A [Day 1 to Day 14]
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part A of the study.
- Percentage of Participants With TEAEs, Graded by Severity - Part A [Day 1 to Day 14]
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with an inability to perform normal activities). The analysis was performed in participants included in Part A of the study.
- Change From Baseline (CFB) in Basophils - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%).
- CFB in Eosinophils - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Eosinophils to Leukocytes Ratio (%) - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Erythrocytes - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Hematocrit - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Hemoglobin - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Leukocytes - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Lymphocytes - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Lymphocytes to Leukocytes Ratio (%) - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Monocytes - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Monocytes to Leukocytes Ratio (%) - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Neutrophils- Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Neutrophils to Leukocytes Ratio (%) - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Platelets - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Reticulocytes - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Activated Partial Thromboplastin Time - Part A [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Prothrombin International Normalized Ratio - Part A [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Prothrombin Time - Part A [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Alanine Aminotransferase - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Albumin - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Alkaline Phosphatase - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Aspartate Aminotransferase - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Bicarbonate - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Bilirubin - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Calcium - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Chloride - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Creatinine - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Lipase - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Magnesium - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Phosphate - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Potassium - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Protein - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Sodium - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Urate - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Urea Nitrogen - Part A [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Specific Gravity - Part A [Day 1 to Day 14]
Urinalysis measures included specific gravity and potential of hydrogen (pH). Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study.
- CFB in pH - Part A [Day 1 to Day 14]
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study.
- CFB in Temperature - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Heart Rate - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Respiratory Rate - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Supine Systolic Blood Pressure - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Standing Systolic Blood Pressure - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Supine Diastolic Blood Pressure - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Standing Diastolic Blood Pressure - Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Pulse Oximetry- Part A [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Aggregate PR Interval - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Aggregate RR Interval - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Aggregate QT Interval - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Aggregate QRS Duration - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Aggregate QTcF Interval - Part A [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- CFB in Stanford Sleepiness Scale (SSS) Score - Part A [Day 1 to Day 14]
The SSS was a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study.
- Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A [Day 1 to Day 14]
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part A of the study.
- CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B [Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
The modified MDS-UPDRS included 4 scales, with various subscales. Each item was rated from 0 (normal) to 4 (severe). The scales were Part I: nonmotor experiences of daily living (13 items); Part II: motor experiences of daily living (13 items); Part III: motor examination (33 scores based on 18 items [several with right, left or other body distribution scores]); and Part IV: motor complications (6 items). The Part II/III tremor score was calculated as the sum of 5 individual tremor item scores from Part II and Part III. The total score range for Part II/III is 0 to 44. Lower scores represent less symptom severity and higher scores represent more symptom severity. Baseline is the last measurement taken before the first dose of study drug. A negative change from baseline indicates an improvement in symptom severity. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
Secondary Outcome Measures
- MDS-UPDRS Part III Total Score - Part A [Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14]
Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores indicate less symptom severity. The analysis was performed in participants included in Part A of the study.
- CFB in the MDS-UPDRS Part III Total Score - Part B [Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of the individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores represent less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in the MDS-UPDRS Part I Total Score - Part B [Baseline, Day 7 (12 hours postdose), Day 14]
Part I of the MDS-UPDRS assessed 13 nonmotor experiences of daily living categories. Part I total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in the MDS-UPDRS Part II Total Score - Part B [Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14]
Part II of the MDS-UPDRS assessed 13 categories of motor experiences of daily living: speech, salivation and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, car, or deep chair, walking and balance, and freezing. The Part II total score was calculated as the sum of the individual item scores from these categories. The total score range for Part II is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in the MDS-UPDRS Part I-IV Total Score - Part B [Baseline, Day 7 (12 hours postdose), Day 14]
The MDS-UPDRS assesses nonmotor experiences, motor experiences, motor skills, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I-IV is 0 to 260. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- Percentage of Participants With TEAEs - Part B [Day 1 to Day 14]
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part B of the study.
- Percentage of Participants With TEAEs, Graded by Severity - Part B [Day 1 to Day 14]
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study.
- CFB in Basophils - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Basophils to Leukocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Eosinophils - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Eosinophils to Leukocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Erythrocytes - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Hematocrit - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Hemoglobin - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Leukocytes - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Lymphocytes - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Lymphocytes to Leukocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Monocytes - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Monocytes to Leukocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Neutrophils - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Neutrophils to Leukocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Platelets - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Reticulocytes - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B [Day 1 to Day 14]
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
- CFB in Activated Partial Thromboplastin Time - Part B [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Prothrombin International Normalized Ratio - Part B [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Prothrombin Time - Part B [Day 1 to Day 14]
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Alanine Aminotransferase - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Albumin - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Alkaline Phosphatase - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aspartate Aminotransferase - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Bicarbonate - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Bilirubin - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Calcium - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Chloride - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Creatinine - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Lipase - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Magnesium - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Phosphate - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Potassium - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Protein - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Sodium - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Urate - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Urea Nitrogen - Part B [Day 1 to Day 14]
Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Specific Gravity - Part B [Day 1 to Day 14]
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in pH - Part B [Day 1 to Day 14]
Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Temperature - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Heart Rate - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Respiratory Rate - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Supine Systolic Blood Pressure - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Standing Systolic Blood Pressure - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Supine Diastolic Blood Pressure - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Standing Diastolic Blood Pressure - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Pulse Oximetry - Part B [Day 1 to Day 14]
Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in ECG Mean Heart Rate - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aggregate PR Interval - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aggregate RR Interval - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aggregate QT Interval - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aggregate QRS Duration - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- CFB in Aggregate QTcF Interval - Part B [Day 1 to Day 14]
ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study.
- Percentage of Participants With a Response of 'Yes' to Any C-SSRS Suicidal Ideation or Suicidal Behavior Item - Part B [Day 1 to Day 14]
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part B of the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 2 or Stage 3) with a duration of less than 7 years prior to screening [Part A]
-
Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 1-4, assessed during the "on" period) [Part B]
-
Participant is on a stable dose (at least 1 month prior to baseline visit) of an antiparkinsonian agent and is willing to remain on this dose for the duration of the study
Exclusion Criteria:
-
Participant has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or Stage 5) Parkinson's Disease [Part A]
-
Participant has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease [Part B]
-
Participant with presence of drug-induced parkinsonism, metabolic identified neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes
-
Participant with medical history of electroconvulsive therapy or stereotaxic brain surgery for Parkinson's Disease
-
Participant with medical history of suicide attempt within 2 years of screening or current suicidal ideation
-
Participant with medical history of impulse control disorder
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sage Investigational Site | Panorama City | California | United States | 91402 |
2 | Sage Investigational Site | Jacksonville | Florida | United States | 32216 |
3 | Sage Investigational Site | Miami | Florida | United States | 33135 |
4 | Sage Investigational Site | Miami | Florida | United States | 33143 |
5 | Sage Investigational Site | Orlando | Florida | United States | 32806 |
6 | Sage Investigational Site | Winter Park | Florida | United States | 32789 |
7 | Sage Investigational Site | Atlanta | Georgia | United States | 30331 |
8 | Sage Investigational Site | Farmington Hills | Michigan | United States | 48334 |
9 | Sage Investigational Site | Berlin | New Jersey | United States | 08009 |
10 | Sage Investigational Site | Houston | Texas | United States | 77058 |
11 | Sage Investigational Site | Orem | Utah | United States | 84058 |
Sponsors and Collaborators
- Sage Therapeutics
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 217-PRK-201
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at 9 sites in the United States and took part in the study which ran from 30 November 2016 to 11 September 2017. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Period Title: Overall Study | ||
STARTED | 15 | 14 |
COMPLETED | 14 | 14 |
NOT COMPLETED | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 | Part B: Antiparkinsonian Agent(s) + SAGE-217 | Total |
---|---|---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. | Total of all reporting groups |
Overall Participants | 15 | 14 | 29 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.9
(6.59)
|
65.1
(7.76)
|
64.5
(7.17)
|
Sex: Female, Male (Count of Participants) | |||
Female |
7
46.7%
|
5
35.7%
|
12
41.4%
|
Male |
8
53.3%
|
9
64.3%
|
17
58.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
13.3%
|
7
50%
|
9
31%
|
Not Hispanic or Latino |
13
86.7%
|
7
50%
|
20
69%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
6.7%
|
1
7.1%
|
2
6.9%
|
White |
14
93.3%
|
12
85.7%
|
26
89.7%
|
More than one race |
0
0%
|
1
7.1%
|
1
3.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A |
---|---|
Description | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Overall number of participants analyzed = Number of participants in the safety population that remained in the study during each period. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Part A: SAGE-217 Day 4 to Day 7 | Part A: Follow-up |
---|---|---|---|
Arm/Group Description | Participants received levodopa as antiparkinsonian agents at the normally prescribed dosing schedule, orally for Days 1 to 3. | Participants received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. If the initial dose was not tolerated, doses could be reduced to 10 or 20 mg per day. | Participants resumed levodopa as antiparkinsonian agents at the normally prescribed dosing schedule for Days 8 to 14. |
Measure Participants | 15 | 14 | 15 |
Number [percentage of participants] |
26.7
178%
|
100
714.3%
|
13.3
45.9%
|
Title | Percentage of Participants With TEAEs, Graded by Severity - Part A |
---|---|
Description | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with an inability to perform normal activities). The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Overall number of participants analyzed = Number of participants in the safety population that remained in the study during each period. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Day 1 to Day 3 | Part A: SAGE-217 Day 4 to Day 7 | Part A: Follow-up |
---|---|---|---|
Arm/Group Description | Participants received levodopa as antiparkinsonian agents at the normally prescribed dosing schedule, orally for Days 1 to 3. | Participants received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. If the initial dose was not tolerated, doses could be reduced to 10 or 20 mg per day. | Participants resumed levodopa as antiparkinsonian agents at the normally prescribed dosing schedule for Days 8 to 14. |
Measure Participants | 15 | 14 | 15 |
Mild |
20.0
133.3%
|
0
0%
|
6.7
23.1%
|
Moderate |
6.7
44.7%
|
85.7
612.1%
|
6.7
23.1%
|
Severe |
0
0%
|
14.3
102.1%
|
0
0%
|
Title | Change From Baseline (CFB) in Basophils - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.06
(0.051)
|
CFB at Day 4 (SAGE-217) |
-0.02
(0.043)
|
CFB at Day 6 (SAGE-217) |
-0.01
(0.036)
|
CFB at Day 8 (Follow-up) |
0.02
(0.038)
|
CFB at Day 14 (Follow-up) |
-0.02
(0.041)
|
Title | CFB in Basophils to Leukocytes Ratio [Percentage (%)] - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.8
(0.41)
|
CFB at Day 4 (SAGE-217) |
0.1
(0.66)
|
CFB at Day 6 (SAGE-217) |
0.3
(0.61)
|
CFB at Day 8 (Follow-up) |
0.0
(0.41)
|
CFB at Day 14 (Follow-up) |
0.1
(0.35)
|
Title | CFB in Eosinophils - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.17
(0.098)
|
CFB at Day 4 (SAGE-217) |
0.07
(0.083)
|
CFB at Day 6 (SAGE-217) |
0.04
(0.051)
|
CFB at Day 8 (Follow-up) |
0.02
(0.073)
|
CFB at Day 14 (Follow-up) |
0.00
(0.053)
|
Title | CFB in Eosinophils to Leukocytes Ratio (%) - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
2.9
(1.58)
|
CFB at Day 4 (SAGE-217) |
0.7
(1.59)
|
CFB at Day 6 (SAGE-217) |
0.3
(0.83)
|
CFB at Day 8 (Follow-up) |
0.0
(0.82)
|
CFB at Day 14 (Follow-up) |
-0.3
(1.11)
|
Title | CFB in Erythrocytes - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
4.63
(0.475)
|
CFB at Day 4 (SAGE-217) |
0.01
(0.266)
|
CFB at Day 6 (SAGE-217) |
0.04
(0.224)
|
CFB at Day 8 (Follow-up) |
0.02
(0.265)
|
CFB at Day 14 (Follow-up) |
-0.09
(0.226)
|
Title | CFB in Hematocrit - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.434
(0.0444)
|
CFB at Day 4 (SAGE-217) |
0.003
(0.0264)
|
CFB at Day 6 (SAGE-217) |
0.004
(0.0247)
|
CFB at Day 8 (Follow-up) |
-0.002
(0.0285)
|
CFB at Day 14 (Follow-up) |
-0.013
(0.0222)
|
Title | CFB in Hemoglobin - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
142.0
(13.87)
|
CFB at Day 4 (SAGE-217) |
0.1
(7.55)
|
CFB at Day 6 (SAGE-217) |
1.7
(7.25)
|
CFB at Day 8 (Follow-up) |
1.2
(8.14)
|
CFB at Day 14 (Follow-up) |
-1.9
(5.82)
|
Title | CFB in Leukocytes - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
6.04
(1.139)
|
CFB at Day 4 (SAGE-217) |
-0.24
(1.085)
|
CFB at Day 6 (SAGE-217) |
0.15
(0.536)
|
CFB at Day 8 (Follow-up) |
-0.09
(0.874)
|
CFB at Day 14 (Follow-up) |
0.30
(0.941)
|
Title | CFB in Lymphocytes - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.. |
Measure Participants | 15 |
Baseline |
1.70
(0.318)
|
CFB at Day 4 (SAGE-217) |
-0.02
(0.289)
|
CFB at Day 6 (SAGE-217) |
0.07
(0.352)
|
CFB at Day 8 (Follow-up) |
0.02
(0.286)
|
CFB at Day 14 (Follow-up) |
-0.17
(0.183)
|
Title | CFB in Lymphocytes to Leukocytes Ratio (%) - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
28.3
(4.68)
|
CFB at Day 4 (SAGE-217) |
1.0
(4.72)
|
CFB at Day 6 (SAGE-217) |
1.0
(5.55)
|
CFB at Day 8 (Follow-up) |
0.9
(4.87)
|
CFB at Day 14 (Follow-up) |
-3.9
(4.22)
|
Title | CFB in Monocytes - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.36
(0.112)
|
CFB at Day 4 (SAGE-217) |
0.02
(0.125)
|
CFB at Day 6 (SAGE-217) |
0.06
(0.076)
|
CFB at Day 8 (Follow-up) |
0.02
(0.101)
|
CFB at Day 14 (Follow-up) |
0.05
(0.064)
|
Title | CFB in Monocytes to Leukocytes Ratio (%) - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
6.1
(1.06)
|
CFB at Day 4 (SAGE-217) |
0.2
(1.48)
|
CFB at Day 6 (SAGE-217) |
0.6
(1.45)
|
CFB at Day 8 (Follow-up) |
0.5
(1.33)
|
CFB at Day 14 (Follow-up) |
0.3
(1.22)
|
Title | CFB in Neutrophils- Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
3.79
(0.861)
|
CFB at Day 4 (SAGE-217) |
-0.27
(0.848)
|
CFB at Day 6 (SAGE-217) |
-0.03
(0.599)
|
CFB at Day 8 (Follow-up) |
-0.17
(0.680)
|
CFB at Day 14 (Follow-up) |
0.44
(0.861)
|
Title | CFB in Neutrophils to Leukocytes Ratio (%) - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
62.5
(4.26)
|
CFB at Day 4 (SAGE-217) |
-2.4
(4.94)
|
CFB at Day 6 (SAGE-217) |
-2.4
(5.58)
|
CFB at Day 8 (Follow-up) |
-2.2
(4.86)
|
CFB at Day 14 (Follow-up) |
3.6
(4.64)
|
Title | CFB in Platelets - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
218.9
(62.00)
|
CFB at Day 4 (SAGE-217) |
6.6
(27.07)
|
CFB at Day 6 (SAGE-217) |
6.8
(33.01)
|
CFB at Day 8 (Follow-up) |
7.8
(21.29)
|
CFB at Day 14 (Follow-up) |
11.5
(36.42)
|
Title | CFB in Reticulocytes - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
64.6
(20.36)
|
CFB at Day 4 (SAGE-217) |
-0.3
(17.87)
|
CFB at Day 6 (SAGE-217) |
0.3
(19.21)
|
CFB at Day 8 (Follow-up) |
0.2
(20.18)
|
CFB at Day 14 (Follow-up) |
0.3
(14.10)
|
Title | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part A |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
1.41
(0.442)
|
CFB at Day 4 (SAGE-217) |
0.00
(0.349)
|
CFB at Day 6 (SAGE-217) |
-0.03
(0.409)
|
CFB at Day 8 (Follow-up) |
0.00
(0.424)
|
CFB at Day 14 (Follow-up) |
0.03
(0.315)
|
Title | CFB in Activated Partial Thromboplastin Time - Part A |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 13 |
Baseline |
24.80
|
CFB at Day 4 (SAGE-217) |
0.20
|
CFB at Day 6 (SAGE-217) |
-0.25
|
CFB at Day 8 (Follow-up) |
-0.10
|
CFB at Day 14 (Follow-up) |
-1.10
|
Title | CFB in Prothrombin International Normalized Ratio - Part A |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 13 |
Baseline |
1.04
(0.065)
|
CFB at Day 4 (SAGE-217) |
0.01
(0.108)
|
CFB at Day 6 (SAGE-217) |
-0.03
(0.065)
|
CFB at Day 8 (Follow-up) |
0.05
(0.243)
|
CFB at Day 14 (Follow-up) |
0.01
(0.155)
|
Title | CFB in Prothrombin Time - Part A |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 13 |
Baseline |
10.70
|
CFB at Day 4 (SAGE-217) |
0.00
|
CFB at Day 6 (SAGE-217) |
0.00
|
CFB at Day 8 (Follow-up) |
0.10
|
CFB at Day 14 (Follow-up) |
-0.10
|
Title | CFB in Alanine Aminotransferase - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
15.8
(8.12)
|
CFB at Day 4 (SAGE-217) |
15.3
(11.61)
|
CFB at Day 6 (SAGE-217) |
13.9
(11.87)
|
CFB at Day 8 (Follow-up) |
7.2
(13.64)
|
CFB at Day 14 (Follow-up) |
2.3
(9.24)
|
Title | CFB in Albumin - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
43.2
(1.70)
|
CFB at Day 4 (SAGE-217) |
-1.2
(1.81)
|
CFB at Day 6 (SAGE-217) |
-0.4
(2.59)
|
CFB at Day 8 (Follow-up) |
-0.1
(2.21)
|
CFB at Day 14 (Follow-up) |
-0.3
(2.35)
|
Title | CFB in Alkaline Phosphatase - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
80.6
(14.17)
|
CFB at Day 4 (SAGE-217) |
-1.7
(9.34)
|
CFB at Day 6 (SAGE-217) |
-2.4
(4.52)
|
CFB at Day 8 (Follow-up) |
-0.5
(4.78)
|
CFB at Day 14 (Follow-up) |
0.0
(8.06)
|
Title | CFB in Aspartate Aminotransferase - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
23.2
(7.24)
|
CFB at Day 4 (SAGE-217) |
-0.4
(6.15)
|
CFB at Day 6 (SAGE-217) |
-2.4
(4.93)
|
CFB at Day 8 (Follow-up) |
-1.0
(5.25)
|
CFB at Day 14 (Follow-up) |
1.8
(5.16)
|
Title | CFB in Bicarbonate - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
22.4
(2.50)
|
CFB at Day 4 (SAGE-217) |
-0.9
(2.27)
|
CFB at Day 6 (SAGE-217) |
0.3
(2.23)
|
CFB at Day 8 (Follow-up) |
-0.1
(2.41)
|
CFB at Day 14 (Follow-up) |
0.7
(2.26)
|
Title | CFB in Bilirubin - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
6.082
(3.8041)
|
CFB at Day 4 (SAGE-217) |
-0.029
(3.4758)
|
CFB at Day 6 (SAGE-217) |
0.949
(3.8554)
|
CFB at Day 8 (Follow-up) |
1.545
(3.5965)
|
CFB at Day 14 (Follow-up) |
0.543
(3.7159)
|
Title | CFB in Calcium - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
2.342
(0.0588)
|
CFB at Day 4 (SAGE-217) |
-0.030
(0.0734)
|
CFB at Day 6 (SAGE-217) |
0.007
(0.0779)
|
CFB at Day 8 (Follow-up) |
-0.014
(0.0711)
|
CFB at Day 14 (Follow-up) |
-0.015
(0.0842)
|
Title | CFB in Chloride - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
100.1
(2.33)
|
CFB at Day 4 (SAGE-217) |
1.6
(1.91)
|
CFB at Day 6 (SAGE-217) |
1.1
(2.30)
|
CFB at Day 8 (Follow-up) |
0.5
(2.41)
|
CFB at Day 14 (Follow-up) |
0.3
(1.83)
|
Title | CFB in Creatinine - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
73.254
(17.7960)
|
CFB at Day 4 (SAGE-217) |
2.399
(8.6574)
|
CFB at Day 6 (SAGE-217) |
4.104
(9.4424)
|
CFB at Day 8 (Follow-up) |
4.420
(10.9866)
|
CFB at Day 14 (Follow-up) |
0.118
(4.6761)
|
Title | CFB in Lipase - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
34.5
(10.16)
|
CFB at Day 4 (SAGE-217) |
16.6
(22.15)
|
CFB at Day 6 (SAGE-217) |
35.1
(77.58)
|
CFB at Day 8 (Follow-up) |
73.3
(222.02)
|
CFB at Day 14 (Follow-up) |
-1.6
(7.67)
|
Title | CFB in Magnesium - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.861
(0.0686)
|
CFB at Day 4 (SAGE-217) |
-0.012
(0.0409)
|
CFB at Day 6 (SAGE-217) |
0.000
(0.0457)
|
CFB at Day 8 (Follow-up) |
0.015
(0.0617)
|
CFB at Day 14 (Follow-up) |
0.016
(0.0618)
|
Title | CFB in Phosphate - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
1.098
(0.1189)
|
CFB at Day 4 (SAGE-217) |
0.035
(0.1413)
|
CFB at Day 6 (SAGE-217) |
0.076
(0.1645)
|
CFB at Day 8 (Follow-up) |
0.083
(0.1513)
|
CFB at Day 14 (Follow-up) |
-0.034
(0.1698)
|
Title | CFB in Potassium - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
4.53
(0.326)
|
CFB at Day 4 (SAGE-217) |
-0.14
(0.323)
|
CFB at Day 6 (SAGE-217) |
-0.08
(0.309)
|
CFB at Day 8 (Follow-up) |
-0.15
(0.350)
|
CFB at Day 14 (Follow-up) |
-0.08
(0.446)
|
Title | CFB in Protein - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
69.4
(3.07)
|
CFB at Day 4 (SAGE-217) |
-2.3
(4.12)
|
CFB at Day 6 (SAGE-217) |
-1.5
(3.86)
|
CFB at Day 8 (Follow-up) |
-0.4
(3.65)
|
CFB at Day 14 (Follow-up) |
-1.1
(4.33)
|
Title | CFB in Sodium - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
140.0
(1.73)
|
CFB at Day 4 (SAGE-217) |
0.8
(2.15)
|
CFB at Day 6 (SAGE-217) |
1.3
(1.86)
|
CFB at Day 8 (Follow-up) |
0.7
(2.20)
|
CFB at Day 14 (Follow-up) |
0.5
(1.85)
|
Title | CFB in Urate - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
0.337
(0.1000)
|
CFB at Day 4 (SAGE-217) |
-0.005
(0.0713)
|
CFB at Day 6 (SAGE-217) |
0.010
(0.0804)
|
CFB at Day 8 (Follow-up) |
0.014
(0.0394)
|
CFB at Day 14 (Follow-up) |
-0.014
(0.0649)
|
Title | CFB in Urea Nitrogen - Part A |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
5.831
(1.3672)
|
CFB at Day 4 (SAGE-217) |
0.587
(1.4925)
|
CFB at Day 6 (SAGE-217) |
0.816
(1.4715)
|
CFB at Day 8 (Follow-up) |
0.663
(1.5521)
|
CFB at Day 14 (Follow-up) |
-0.048
(1.3484)
|
Title | CFB in Specific Gravity - Part A |
---|---|
Description | Urinalysis measures included specific gravity and potential of hydrogen (pH). Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
1.018
(0.0049)
|
CFB at Day 4 (SAGE-217) |
-0.001
(0.0062)
|
CFB at Day 7 (SAGE-217) |
0.000
(0.0039)
|
CFB at Day 14 (Follow-up) |
0.002
(0.0059)
|
Title | CFB in pH - Part A |
---|---|
Description | Urinalysis measures included specific gravity and pH. Baseline is the last measurement taken before the first dose of study drug. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
5.87
(0.915)
|
CFB at Day 4 (SAGE-217) |
0.18
(0.973)
|
CFB at Day 7 (SAGE-217) |
-0.11
(0.881)
|
CFB at Day 14 (Follow-up) |
-0.07
(0.884)
|
Title | CFB in Temperature - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
36.61
(0.228)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-0.04
(0.180)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-0.01
(0.205)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-0.05
(0.236)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
-0.08
(0.227)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
-0.06
(0.285)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
0.00
(0.235)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
0.08
(0.412)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
0.00
(0.319)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-0.01
(0.296)
|
CFB at Day 2 (L/C): Predose |
-0.06
(0.346)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
-0.11
(0.316)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
-0.05
(0.348)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-0.04
(0.323)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
-0.07
(0.279)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
-0.11
(0.274)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
-0.02
(0.283)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
0.06
(0.380)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
-0.05
(0.380)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
-0.06
(0.365)
|
CFB at Day 3 (L/C): Predose |
0.09
(0.409)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-0.09
(0.305)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-0.10
(0.277)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-0.10
(0.272)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-0.03
(0.331)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
-0.06
(0.363)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-0.04
(0.276)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
-0.05
(0.422)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
-0.01
(0.372)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
0.04
(0.176)
|
CFB at Day 4 (SAGE-217): Predose |
0.02
(0.208)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
0.01
(0.175)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
0.08
(0.387)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
-0.07
(0.236)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-0.11
(0.236)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
0.03
(0.230)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
-0.03
(0.336)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
-0.02
(0.333)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
0.12
(0.185)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
0.07
(0.233)
|
CFB at Day 5 (SAGE-217): Predose |
-0.05
(0.187)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-0.04
(0.287)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-0.16
(0.360)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
-0.17
(0.272)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
-0.02
(0.449)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
-0.16
(0.310)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
-0.07
(0.421)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-0.09
(0.400)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
-0.07
(0.273)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
-0.02
(0.383)
|
CFB at Day 6 (SAGE-217): Predose |
-0.04
(0.359)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
0.02
(0.306)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
-0.08
(0.322)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-0.13
(0.322)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-0.12
(0.358)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
-0.09
(0.260)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
-0.08
(0.329)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
-0.10
(0.697)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
-0.04
(0.434)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
0.06
(0.434)
|
CFB at Day 7 (SAGE-217): Predose |
-0.13
(0.302)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-0.16
(0.282)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-0.16
(0.407)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-0.16
(0.310)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
-0.11
(0.332)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
-0.13
(0.252)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
0.02
(0.208)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
0.06
(0.145)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
-0.01
(0.235)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
-0.03
(0.363)
|
CFB at Day 8 (Follow-up) |
0.4
(0.224)
|
CFB at Day 14 (Follow-up) |
0.07
(0.301)
|
Title | CFB in Heart Rate - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
66.6
(11.83)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
2.1
(5.87)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
1.3
(6.76)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-0.5
(5.87)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
-1.3
(6.63)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
0.8
(7.75)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
0.4
(7.55)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
5.5
(6.86)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
0.5
(7.18)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
1.4
(5.03)
|
CFB at Day 2 (L/C): Predose |
-0.2
(6.80)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
2.1
(7.37)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
1.9
(8.10)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-0.3
(10.71)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
-0.9
(5.23)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
2.1
(7.08)
|
CFB at Day 2 (L/C): 8 Hours Postdos |
3.8
(7.81)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
3.9
(8.38)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
1.6
(7.29)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
1.2
(7.29)
|
CFB at Day 3 (L/C): Predose |
-0.7
(9.29)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
4.7
(6.67)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
2.4
(9.46)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
1.2
(7.20)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
0.6
(6.30)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
1.7
(7.33)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
5.9
(5.43)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
2.6
(9.72)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
3.6
(8.63)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
3.9
(7.08)
|
CFB at Day 4 (SAGE-217): Predose |
1.4
(5.21)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
3.7
(6.43)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
1.6
(8.97)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
3.4
(10.38)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
0.6
(6.27)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
2.7
(8.72)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
2.1
(7.97)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
5.1
(9.70)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
5.2
(6.64)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
4.6
(7.37)
|
CFB at Day 5 (SAGE-217): Predose |
1.5
(8.25)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
3.8
(6.99)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
4.4
(9.06)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
3.4
(8.18)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
1.3
(11.03)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
7.6
(11.24)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
4.2
(9.50)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
8.4
(9.51)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
6.6
(7.98)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
3.7
(9.34)
|
CFB at Day 6 (SAGE-217): Predose |
4.6
(7.58)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
4.3
(6.53)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
2.9
(7.86)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
4.2
(7.51)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
3.2
(10.09)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
5.1
(10.07)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
4.6
(11.00)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
4.8
(10.87)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
5.2
(9.51)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
5.4
(10.87)
|
CFB at Day 7 (SAGE-217): Predose |
8.4
(11.06)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
6.0
(8.29)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
5.3
(6.49)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
3.9
(12.50)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
4.4
(7.77)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
6.0
(8.46)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
4.8
(4.66)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
9.5
(9.82)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
6.7
(9.27)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
5.6
(7.93)
|
CFB at Day 8 (Follow-up) |
1.8
(6.52)
|
CFB at Day 14 (Follow-up) |
4.1
(8.29)
|
Title | CFB in Respiratory Rate - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
15.9
(1.92)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
0.1
(1.46)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
0.1
(1.92)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
0.0
(1.69)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
0.2
(1.93)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
0.0
(1.69)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
1.0
(2.08)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
0.6
(1.99)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
0.1
(1.83)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-0.2
(2.49)
|
CFB at Day 2 (L/C): Predose |
-0.1
(1.59)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
0.1
(1.83)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
0.2
(1.48)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
0.0
(1.57)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
0.5
(1.70)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
0.4
(2.14)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
0.1
(2.32)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
0.3
(2.61)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
0.3
(2.92)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
0.1
(2.62)
|
CFB at Day 3 (L/C): Predose |
-0.4
(1.99)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
0.4
(1.65)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-0.1
(2.03)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
0.4
(2.13)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
0.1
(2.11)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
0.4
(1.87)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
0.2
(2.26)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
0.4
(1.65)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
0.2
(1.93)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
0.0
(2.74)
|
CFB at Day 4 (SAGE-217): Predose |
0.9
(1.59)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-0.3
(2.69)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
-0.4
(2.79)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
0.3
(2.39)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-0.1
(1.66)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
0.1
(1.21)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
0.7
(1.68)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
0.9
(1.86)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
0.5
(1.70)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
-0.3
(2.02)
|
CFB at Day 5 (SAGE-217): Predose |
-0.1
(1.59)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-0.3
(2.20)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-0.4
(2.34)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
-0.1
(1.77)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
0.1
(1.86)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
0.4
(2.27)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
1.0
(1.92)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
0.4
(1.95)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
0.5
(1.95)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
0.3
(2.05)
|
CFB at Day 6 (SAGE-217): Predose |
-0.1
(1.38)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-0.6
(1.65)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
-0.3
(1.38)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-0.1
(2.18)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-0.1
(1.79)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
0.4
(2.21)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
1.0
(1.92)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
0.4
(2.82)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
0.5
(2.10)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
0.4
(2.31)
|
CFB at Day 7 (SAGE-217): Predose |
0.0
(1.36)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
0.1
(1.27)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
0.9
(1.51)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
0.1
(1.49)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
0.1
(1.66)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
0.6
(1.65)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
0.4
(1.65)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
1.4
(2.03)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
0.4
(2.31)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
0.7
(2.61)
|
CFB at Day 8 (Follow-up) |
0.1
(1.29)
|
CFB at Day 14 (Follow-up) |
0.9
(1.83)
|
Title | CFB in Supine Systolic Blood Pressure - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
124.5
(11.61)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-6.7
(10.81)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-7.1
(11.49)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-1.5
(10.37)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
-4.7
(9.44)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
-4.5
(9.63)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
2.4
(13.32)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
3.4
(13.21)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
-3.0
(12.51)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-3.9
(11.99)
|
CFB at Day 2 (L/C): Predose |
-0.4
(11.14)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
-7.3
(11.59)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
-4.4
(9.99)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-0.8
(10.86)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
-1.1
(10.43)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
-1.6
(10.95)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
3.2
(15.35)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
5.9
(8.00)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
3.4
(9.53)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
0.9
(10.40)
|
CFB at Day 3 (L/C): Predose |
1.2
(8.61)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-2.5
(10.30)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-7.4
(14.70)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-3.1
(12.69)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-3.7
(14.12)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
-3.1
(12.51)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-1.3
(12.75)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
3.3
(13.30)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
3.6
(16.21)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
-3.3
(10.73)
|
CFB at Day 4 (SAGE-217): Predose |
3.5
(10.17)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-4.8
(9.75)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
-6.6
(10.80)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
2.3
(15.97)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-1.6
(8.84)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
-3.9
(10.46)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
2.2
(10.94)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
3.1
(9.60)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
-3.1
(14.15)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
-2.6
(10.83)
|
CFB at Day 5 (SAGE-217): Predose |
0.1
(11.43)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-8.6
(9.68)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-8.1
(11.67)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
-5.8
(10.14)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
-0.4
(9.23)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
-2.9
(11.14)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
-3.8
(10.15)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
1.3
(11.68)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
1.7
(15.46)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
0.6
(14.19)
|
CFB at Day 6 (SAGE-217): Predose |
-5.9
(11.67)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-8.6
(11.95)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
-3.8
(13.03)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-4.1
(15.47)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-5.6
(13.00)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
-4.4
(10.23)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
-0.1
(12.46)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
-0.1
(12.41)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
2.5
(10.39)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
1.8
(13.45)
|
CFB at Day 7 (SAGE-217): Predose |
1.9
(19.64)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-5.9
(12.93)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-5.4
(18.93)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-2.8
(13.22)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
-5.1
(17.35)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
-3.9
(14.81)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
-3.1
(10.38)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
2.9
(13.23)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
-0.6
(14.07)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
-0.2
(18.75)
|
CFB at Day 8 (Follow-up) |
1.7
(7.79)
|
CFB at Day 14 (Follow-up) |
2.7
(9.50)
|
Title | CFB in Standing Systolic Blood Pressure - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
124.1
(12.38)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-3.1
(9.98)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-4.7
(10.00)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-2.9
(11.45)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
0.0
(11.78)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
2.7
(13.34)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
4.3
(10.22)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
7.6
(17.85)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
2.9
(10.18)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-2.7
(9.51)
|
CFB at Day 2 (L/C): Predose |
1.0
(11.09)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
-2.9
(10.57)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
-3.4
(11.56)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-5.1
(9.86)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
0.0
(10.12)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
-3.4
(8.50)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
-0.6
(10.20)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
5.6
(16.97)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
2.0
(11.08)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
-4.4
(10.14)
|
CFB at Day 3 (L/C): Predose |
-1.4
(7.84)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-4.2
(8.17)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-4.9
(11.83)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-4.4
(13.07)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-6.2
(13.13)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
-3.2
(9.35)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-3.2
(10.83)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
1.8
(14.56)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
0.0
(15.65)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
2.2
(11.98)
|
CFB at Day 4 (SAGE-217): Predose |
3.3
(13.32)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-1.5
(14.74)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
-4.6
(10.60)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
-0.5
(11.77)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-5.7
(10.04)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
-2.3
(8.50)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
0.9
(9.16)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
3.3
(12.72)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
0.0
(10.09)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
-1.3
(10.07)
|
CFB at Day 5 (SAGE-217): Predose |
-0.6
(9.61)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-9.8
(12.60)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-8.3
(10.52)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
-3.8
(14.81)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
-2.4
(9.82)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
-2.1
(12.05)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
-3.3
(10.16)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
1.4
(12.51)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
2.3
(17.97)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
0.8
(15.37)
|
CFB at Day 6 (SAGE-217): Predose |
-3.3
(12.00)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-6.4
(10.89)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
-5.5
(9.34)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-3.5
(10.36)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-2.8
(8.55)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
1.6
(9.45)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
-2.7
(12.79)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
-2.9
(12.13)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
2.5
(13.57)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
0.6
(19.21)
|
CFB at Day 7 (SAGE-217): Predose |
-0.2
(12.25)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-4.0
(13.06)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-4.7
(13.19)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-6.0
(9.27)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
-5.9
(13.96)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
-2.4
(13.65)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
2.1
(10.80)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
4.6
(14.54)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
3.7
(13.23)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
0.5
(11.95)
|
CFB at Day 8 (Follow-up) |
7.6
(9.90)
|
CFB at Day 14 (Follow-up) |
3.6
(13.14)
|
Title | CFB in Supine Diastolic Blood Pressure - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
77.3
(7.19)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-5.3
(6.02)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-4.7
(5.92)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-3.2
(6.66)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
-3.1
(5.26)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
-3.9
(9.91)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
-0.4
(9.04)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
-0.1
(7.89)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
-3.6
(8.94)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-5.0
(10.34)
|
CFB at Day 2 (L/C): Predose |
0.7
(7.10)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
-4.8
(9.49)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
-3.4
(9.90)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-2.2
(11.37)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
-2.5
(7.78)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
-1.4
(10.09)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
-1.4
(10.47)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
0.9
(7.57)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
-1.9
(8.08)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
-3.4
(7.13)
|
CFB at Day 3 (L/C): Predose |
-0.8
(7.29)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-5.1
(8.51)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-3.1
(8.11)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-4.3
(9.77)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-5.9
(13.63)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
-4.1
(8.77)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-3.9
(9.90)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
-1.0
(8.32)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
-0.9
(7.80)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
-2.5
(8.69)
|
CFB at Day 4 (SAGE-217): Predose |
1.8
(7.82)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-1.9
(6.72)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
-3.6
(6.48)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
1.5
(8.19)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-0.8
(8.01)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
-3.6
(8.75)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
-1.7
(7.08)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
0.0
(6.93)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
-3.6
(8.84)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
-4.0
(7.05)
|
CFB at Day 5 (SAGE-217): Predose |
-2.1
(8.43)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-5.4
(7.72)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-2.4
(6.17)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
-3.1
(6.62)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
-3.3
(6.93)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
-2.4
(8.22)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
-3.4
(7.00)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-4.0
(9.17)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
-4.3
(7.84)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
-2.2
(10.02)
|
CFB at Day 6 (SAGE-217): Predose |
-3.6
(7.59)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-3.7
(9.72)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
-2.7
(9.31)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-1.8
(8.99)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-1.8
(11.37)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
-3.9
(8.09)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
-1.7
(8.06)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
-1.0
(9.17)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
0.8
(7.71)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
-3.6
(10.30)
|
CFB at Day 7 (SAGE-217): Predose |
-1.9
(6.75)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-5.1
(7.79)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-3.5
(9.61)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-2.7
(10.46)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
-4.5
(9.40)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
-4.8
(8.58)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
-2.2
(10.02)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-1.0
(8.58)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
-3.5
(10.65)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
-4.2
(9.66)
|
CFB at Day 8 (Follow-up) |
-3.8
(8.05)
|
CFB at Day 14 (Follow-up) |
-2.2
(7.22)
|
Title | CFB in Standing Diastolic Blood Pressure - Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
76.7
(10.57)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
0.4
(8.71)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-2.9
(7.26)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
0.7
(7.92)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
2.3
(5.57)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
0.9
(10.54)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
3.1
(7.16)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
2.6
(7.04)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
1.3
(7.65)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
1.6
(7.19)
|
CFB at Day 2 (L/C): Predose |
4.0
(8.41)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
1.6
(7.89)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
1.1
(12.25)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
1.1
(8.53)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
3.8
(10.08)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
0.3
(12.55)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
1.6
(10.91)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
4.3
(6.80)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
3.7
(5.99)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
0.1
(5.34)
|
CFB at Day 3 (L/C): Predose |
4.4
(7.82)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-1.1
(9.44)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-0.9
(6.98)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-1.7
(12.74)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-0.7
(11.23)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
-0.6
(9.94)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-1.0
(11.90)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
0.6
(7.43)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
1.8
(9.57)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
3.8
(10.98)
|
CFB at Day 4 (SAGE-217): Predose |
4.6
(9.11)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
1.8
(8.09)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
2.4
(6.86)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
5.6
(7.50)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
3.7
(7.90)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
0.3
(8.17)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
1.9
(7.88)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
4.8
(11.13)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
1.9
(10.41)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
2.8
(9.24)
|
CFB at Day 5 (SAGE-217): Predose |
2.6
(5.84)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-2.5
(5.99)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-0.8
(6.66)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
3.8
(6.44)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
2.7
(6.34)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
1.6
(6.21)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
0.1
(8.02)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
0.2
(9.27)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
0.4
(9.18)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
0.8
(9.71)
|
CFB at Day 6 (SAGE-217): Predose |
-0.4
(8.56)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
0.9
(7.45)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
0.8
(7.10)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
2.0
(10.43)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
1.2
(8.84)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
1.6
(7.06)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
2.3
(9.25)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
0.7
(9.63)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
3.1
(8.10)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
2.8
(11.44)
|
CFB at Day 7 (SAGE-217): Predose |
2.4
(8.24)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
0.3
(8.72)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-2.0
(7.54)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-0.2
(6.47)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
-1.4
(9.98)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
-0.9
(7.85)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
2.7
(6.91)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
2.0
(10.58)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
2.9
(11.34)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
1.1
(9.31)
|
CFB at Day 8 (Follow-up) |
2.1
(7.47)
|
CFB at Day 14 (Follow-up) |
1.5
(8.06)
|
Title | CFB in Pulse Oximetry- Part A |
---|---|
Description | Vital sign measures included temperature, heart rate, respiratory rate, supine systolic blood pressure, standing systolic blood pressure, supine diastolic blood pressure, standing diastolic blood pressure and pulse oximetry. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
96.9
(2.22)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-0.3
(1.03)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
0.2
(1.42)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
0.2
(1.90)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
0.1
(2.02)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
-0.2
(1.42)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
-0.1
(1.23)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
-0.1
(1.46)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
-0.4
(1.08)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
-0.7
(2.64)
|
CFB at Day 2 (L/C): Predose |
-0.6
(1.50)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
-0.4
(2.02)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
-0.4
(1.83)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
-0.2
(0.97)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
-0.7
(2.02)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
-0.5
(2.38)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
0.4
(1.91)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
-0.1
(1.17)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
-0.6
(1.28)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
-0.2
(1.31)
|
CFB at Day 3 (L/C): Predose |
-0.5
(1.79)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
-1.1
(1.86)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
-0.4
(1.70)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
-0.3
(1.44)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
-0.1
(1.33)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
0.3
(1.59)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
-0.1
(1.90)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
0.0
(1.36)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
0.4
(1.28)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
-0.2
(1.63)
|
CFB at Day 4 (SAGE-217): Predose |
0.0
(0.96)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-1.6
(3.69)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
-0.7
(2.73)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
-0.1
(1.82)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
-0.4
(1.09)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
-0.4
(1.87)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
-0.4
(1.28)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
-0.1
(1.29)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
-0.2
(1.42)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
-0.3
(1.68)
|
CFB at Day 5 (SAGE-217): Predose |
0.2
(1.76)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-1.3
(2.61)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
-1.2
(2.72)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
0.1
(1.82)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
0.0
(1.36)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
-0.2
(1.72)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
-0.1
(1.73)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-0.4
(2.56)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
-0.6
(2.34)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
-1.1
(2.87)
|
CFB at Day 6 (SAGE-217): Predose |
-0.5
(1.61)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-1.1
(1.59)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
0.1
(2.37)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
-0.9
(2.03)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
-0.4
(2.34)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
0.1
(2.09)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
0.0
(1.52)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
0.0
(1.84)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
-0.4
(1.79)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
0.1
(2.27)
|
CFB at Day 7 (SAGE-217): Predose |
0.3
(1.38)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-1.4
(2.28)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
-0.4
(2.92)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
-0.5
(2.50)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
0.4
(1.45)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
0.3
(0.99)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
0.3
(1.33)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
0.3
(1.94)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
0.3
(1.59)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
0.2
(1.76)
|
CFB at Day 8 (Follow-up) |
0.3
(1.27)
|
CFB at Day 14 (Follow-up) |
0.5
(1.77)
|
Title | CFB in Electrocardiogram (ECG) Mean Heart Rate - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
64.7
(11.85)
|
CFB at Day 3 (L/C): Predose |
-0.5
(6.77)
|
CFB at Day 4 (SAGE-217): Predose |
1.3
(6.78)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
6.9
(7.65)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
7.1
(8.89)
|
CFB at Day 5 (SAGE-217): Predose |
2.5
(5.53)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
8.2
(5.31)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
9.0
(10.71)
|
CFB at Day 6 (SAGE-217): Predose |
3.7
(4.50)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
5.9
(7.11)
|
Day 6 (SAGE-217): 12 Hours Postdose |
8.5
(5.37)
|
CFB at Day 7 (SAGE-217): Predose |
5.9
(8.76)
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
6.2
(6.03)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
10.7
(6.78)
|
CFB at Day 8 (Follow-up) |
0.9
(4.17)
|
CFB at Day 14 (Follow-up) |
4.7
(9.32)
|
Title | CFB in Aggregate PR Interval - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
158.0
|
CFB at Day 3 (L/C): Predose |
2.0
|
CFB at Day 4 (SAGE-217): Predose |
-2.0
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-2.0
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
-8.0
|
CFB at Day 5 (SAGE-217): Predose |
-1.0
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-6.0
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-1.0
|
CFB at Day 6 (SAGE-217): Predose |
-3.0
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-5.0
|
Day 6 (SAGE-217): 12 Hours Postdose |
-1.5
|
CFB at Day 7 (SAGE-217): Predose |
-1.0
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-2.5
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-2.0
|
CFB at Day 8 (Follow-up) |
-2.5
|
CFB at Day 14 (Follow-up) |
-8.0
|
Title | CFB in Aggregate RR Interval - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
950.0
|
CFB at Day 3 (L/C): Predose |
-32.5
|
CFB at Day 4 (SAGE-217): Predose |
-43.5
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-99.0
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
-98.5
|
CFB at Day 5 (SAGE-217): Predose |
-56.0
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-102.0
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-133.0
|
CFB at Day 6 (SAGE-217): Predose |
-65.0
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-63.0
|
Day 6 (SAGE-217): 12 Hours Postdose |
-113.5
|
CFB at Day 7 (SAGE-217): Predose |
-76.5
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-104.5
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-120.0
|
CFB at Day 8 (Follow-up) |
-10.0
|
CFB at Day 14 (Follow-up) |
-86.0
|
Title | CFB in Aggregate QT Interval - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
406.0
|
CFB at Day 3 (L/C): Predose |
-4.0
|
CFB at Day 4 (SAGE-217): Predose |
-4.5
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-9.0
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
-15.5
|
CFB at Day 5 (SAGE-217): Predose |
-8.5
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
-12.0
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-22.0
|
CFB at Day 6 (SAGE-217): Predose |
-4.5
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-9.0
|
Day 6 (SAGE-217): 12 Hours Postdose |
-13.0
|
CFB at Day 7 (SAGE-217): Predose |
-12.5
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
-13.0
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-23.0
|
CFB at Day 8 (Follow-up) |
0.0
|
CFB at Day 14 (Follow-up) |
-16.0
|
Title | CFB in Aggregate QRS Duration - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
88.0
|
CFB at Day 3 (L/C): Predose |
-1.0
|
CFB at Day 4 (SAGE-217): Predose |
0.0
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
2.0
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
0.0
|
CFB at Day 5 (SAGE-217): Predose |
-2.0
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
0.0
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-1.0
|
CFB at Day 6 (SAGE-217): Predose |
-2.0
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
-0.5
|
Day 6 (SAGE-217): 12 Hours Postdose |
0.0
|
CFB at Day 7 (SAGE-217): Predose |
-2.0
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
0.0
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-1.5
|
CFB at Day 8 (Follow-up) |
-1.0
|
CFB at Day 14 (Follow-up) |
3.0
|
Title | CFB in Aggregate QTcF Interval - Part A |
---|---|
Description | ECG measures included ECG mean heart rate, aggregate PR interval, aggregate RR interval, aggregate QT interval, aggregate QRS duration and aggregate QTcF interval. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
419.0
|
CFB at Day 3 (L/C): Predose |
-1.0
|
CFB at Day 4 (SAGE-217): Predose |
2.0
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
-0.5
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
6.5
|
CFB at Day 5 (SAGE-217): Predose |
-3.0
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
2.0
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
-7.0
|
CFB at Day 6 (SAGE-217): Predose |
4.5
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
0.5
|
Day 6 (SAGE-217): 12 hours postdose |
-2.5
|
CFB at Day 7 (SAGE-217): Predose |
2.0
|
CFB at Day 7 (SAGE-217): 1 Hour Postdose |
0.0
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
-2.5
|
CFB at Day 8 (Follow-up) |
-0.5
|
CFB at Day 14 (Follow-up) |
-7.0
|
Title | CFB in Stanford Sleepiness Scale (SSS) Score - Part A |
---|---|
Description | The SSS was a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. Baseline is the last measurement taken before the first dose of study drug. L/C indicated levodopa/carbidopa. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Baseline |
1.2
(0.56)
|
CFB at Day 1 (L/C): 1 Hour Postdose |
-0.1
(0.26)
|
CFB at Day 1 (L/C): 2 Hours Postdose |
-0.1
(0.26)
|
CFB at Day 1 (L/C): 3 Hours Postdose |
-0.1
(0.52)
|
CFB at Day 1 (L/C): 4 Hours Postdose |
0.0
(0.65)
|
CFB at Day 1 (L/C): 6 Hours Postdose |
0.0
(0.76)
|
CFB at Day 1 (L/C): 8 Hours Postdose |
0.4
(1.39)
|
CFB at Day 1 (L/C): 12 Hours Postdose |
0.2
(0.58)
|
CFB at Day 1 (L/C): 14 Hours Postdose |
0.6
(0.90)
|
CFB at Day 1 (L/C): 16 Hours Postdose |
1.0
(0.85)
|
CFB at Day 2 (L/C): Predose |
0.4
(0.74)
|
CFB at Day 2 (L/C): 1 Hour Postdose |
0.3
(0.73)
|
CFB at Day 2 (L/C): 2 Hours Postdose |
0.2
(0.58)
|
CFB at Day 2 (L/C): 3 Hours Postdose |
0.5
(1.22)
|
CFB at Day 2 (L/C): 4 Hours Postdose |
0.3
(0.91)
|
CFB at Day 2 (L/C): 6 Hours Postdose |
0.5
(1.20)
|
CFB at Day 2 (L/C): 8 Hours Postdose |
0.4
(0.96)
|
CFB at Day 2 (L/C): 12 Hours Postdose |
0.3
(0.47)
|
CFB at Day 2 (L/C): 14 Hours Postdose |
0.6
(0.94)
|
CFB at Day 2 (L/C): 16 Hours Postdose |
0.7
(0.75)
|
CFB at Day 3 (L/C): Predose |
0.3
(0.91)
|
CFB at Day 3 (L/C): 1 Hour Postdose |
0.0
(0.68)
|
CFB at Day 3 (L/C): 2 Hours Postdose |
0.3
(0.91)
|
CFB at Day 3 (L/C): 3 Hours Postdose |
0.3
(1.07)
|
CFB at Day 3 (L/C): 4 Hours Postdose |
0.4
(1.15)
|
CFB at Day 3 (L/C): 6 Hours Postdose |
0.2
(0.90)
|
CFB at Day 3 (L/C): 8 Hours Postdose |
0.3
(0.85)
|
CFB at Day 3 (L/C): 12 Hours Postdose |
0.4
(1.01)
|
CFB at Day 3 (L/C): 14 Hours Postdose |
1.0
(1.18)
|
CFB at Day 3 (L/C): 16 Hours Postdose |
0.7
(0.79)
|
CFB at Day 4 (SAGE-217): Predose |
0.3
(0.61)
|
CFB at Day 4 (SAGE-217): 1 Hour Postdose |
3.2
(2.28)
|
CFB at Day 4 (SAGE-217): 2 Hours Postdose |
2.6
(2.03)
|
CFB at Day 4 (SAGE-217): 3 Hours Postdose |
2.0
(1.57)
|
CFB at Day 4 (SAGE-217): 4 Hours Postdose |
1.2
(1.63)
|
CFB at Day 4 (SAGE-217): 6 Hours Postdose |
0.4
(1.01)
|
CFB at Day 4 (SAGE-217): 8 Hours Postdose |
0.2
(0.93)
|
CFB at Day 4 (SAGE-217): 12 Hours Postdose |
0.2
(0.43)
|
CFB at Day 4 (SAGE-217): 14 Hours Postdose |
0.2
(0.43)
|
CFB at Day 4 (SAGE-217): 16 Hours Postdose |
1.0
(0.82)
|
CFB at Day 5 (SAGE-217): Predose |
0.3
(0.47)
|
CFB at Day 5 (SAGE-217): 1 Hour Postdose |
3.8
(1.79)
|
CFB at Day 5 (SAGE-217): 2 Hours Postdose |
1.8
(1.68)
|
CFB at Day 5 (SAGE-217): 3 Hours Postdose |
1.1
(1.38)
|
CFB at Day 5 (SAGE-217): 4 Hours Postdose |
0.8
(1.42)
|
CFB at Day 5 (SAGE-217): 6 Hours Postdose |
0.6
(0.96)
|
CFB at Day 5 (SAGE-217): 8 Hours Postdose |
0.1
(0.47)
|
CFB at Day 5 (SAGE-217): 12 Hours Postdose |
0.2
(0.43)
|
CFB at Day 5 (SAGE-217): 14 Hours Postdose |
0.4
(0.94)
|
CFB at Day 5 (SAGE-217): 16 Hours Postdose |
0.8
(1.07)
|
CFB at Day 6 (SAGE-217): Predose |
0.1
(0.73)
|
CFB at Day 6 (SAGE-217): 1 Hour Postdose |
2.6
(1.74)
|
CFB at Day 6 (SAGE-217): 2 Hours Postdose |
1.8
(1.85)
|
CFB at Day 6 (SAGE-217): 3 Hours Postdose |
1.6
(2.21)
|
CFB at Day 6 (SAGE-217): 4 Hours Postdose |
1.1
(1.94)
|
CFB at Day 6 (SAGE-217): 6 Hours Postdose |
0.8
(1.30)
|
CFB at Day 6 (SAGE-217): 8 Hours Postdose |
0.3
(0.91)
|
CFB at Day 6 (SAGE-217): 12 Hours Postdose |
0.2
(0.89)
|
CFB at Day 6 (SAGE-217): 14 Hours Postdose |
0.4
(0.74)
|
CFB at Day 6 (SAGE-217): 16 Hours Postdose |
0.9
(1.19)
|
CFB at Day 7 (SAGE-217): Predose |
0.2
(0.58)
|
CFB at Day 7 (SAGE-217): 1 hour postdose |
2.0
(1.66)
|
CFB at Day 7 (SAGE-217): 2 Hours Postdose |
1.3
(1.38)
|
CFB at Day 7 (SAGE-217): 3 Hours Postdose |
0.7
(1.14)
|
CFB at Day 7 (SAGE-217): 4 Hours Postdose |
0.7
(1.33)
|
CFB at Day 7 (SAGE-217): 6 Hours Postdose |
0.1
(0.86)
|
CFB at Day 7 (SAGE-217): 8 Hours Postdose |
0.2
(0.97)
|
CFB at Day 7 (SAGE-217): 12 Hours Postdose |
0.1
(0.83)
|
CFB at Day 7 (SAGE-217): 14 Hours Postdose |
0.4
(1.01)
|
CFB at Day 7 (SAGE-217): 16 Hours Postdose |
0.4
(1.01)
|
CFB at Day 8 (Follow-up) |
-0.1
(0.62)
|
CFB at Day 14 (Follow-up) |
-0.1
(0.59)
|
Title | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item - Part A |
---|---|
Description | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included "yes" or "no"' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with a specific plan. The C-SSRS SB items involved actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior, suicidal behavior and suicide. The analysis was performed in participants included in Part A of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug (SAGE-217 or levodopa). |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Suicidal Ideation: Pre-treatment |
0
0%
|
Suicidal Ideation: Post-treatment |
0
0%
|
Suicidal Behavior: Pre-treatment |
0
0%
|
Suicidal Behavior: Post-treatment |
0
0%
|
Title | CFB in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II/III Score - Part B |
---|---|
Description | The modified MDS-UPDRS included 4 scales, with various subscales. Each item was rated from 0 (normal) to 4 (severe). The scales were Part I: nonmotor experiences of daily living (13 items); Part II: motor experiences of daily living (13 items); Part III: motor examination (33 scores based on 18 items [several with right, left or other body distribution scores]); and Part IV: motor complications (6 items). The Part II/III tremor score was calculated as the sum of 5 individual tremor item scores from Part II and Part III. The total score range for Part II/III is 0 to 44. Lower scores represent less symptom severity and higher scores represent more symptom severity. Baseline is the last measurement taken before the first dose of study drug. A negative change from baseline indicates an improvement in symptom severity. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
19.1
(3.75)
|
CFB at Dose 1 (SAGE-217): 12 Hours Postdose |
-5.4
(4.52)
|
CFB at Dose 1 (SAGE-217): 23 Hours Postdose |
-5.9
(5.15)
|
CFB at Dose 2 (SAGE-217): 12 Hours Postdose |
-6.5
(5.45)
|
CFB at Dose 2 (SAGE-217): 23 Hours Postdose |
-6.6
(4.60)
|
CFB at Dose 3 (SAGE-217): 12 Hours Postdose |
-6.0
(4.51)
|
CFB at Dose 3 (SAGE-217): 23 Hours Postdose |
-5.9
(5.39)
|
CFB at Dose 4 (SAGE-217): 12 Hours Postdose |
-8.0
(5.53)
|
CFB at Dose 4 (SAGE-217): 23 Hours Postdose |
-7.4
(5.02)
|
CFB at Dose 5 (SAGE-217): 12 Hours Postdose |
-7.4
(7.81)
|
CFB at Dose 5 (SAGE-217): 23 Hours Postdose |
-8.0
(5.71)
|
CFB at Dose 6 (SAGE-217): 12 Hours Postdose |
-5.2
(6.93)
|
CFB at Dose 6 (SAGE-217): 23 Hours Postdose |
-8.4
(5.02)
|
CFB at Dose 7 (SAGE-217): 12 Hours Postdose |
-7.7
(4.63)
|
CFB at Day 14 (Follow-up) |
-3.7
(4.34)
|
Title | MDS-UPDRS Part III Total Score - Part A |
---|---|
Description | Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores indicate less symptom severity. The analysis was performed in participants included in Part A of the study. |
Time Frame | Days 1 to 7 (2, 4, 8, and 12 hours postdose), Day 8 and Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part A: Antiparkinsonian Agent(s) Followed by SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14. |
Measure Participants | 15 |
Day 1 (L/C): 2 Hours Postdose |
25.4
(9.34)
|
Day 1 (L/C): 4 Hours Postdose |
30.0
(10.53)
|
Day 1 (L/C): 8 Hours Postdose |
34.3
(10.83)
|
Day 1 (L/C): 12 Hours Postdose |
35.1
(9.71)
|
Day 2 (L/C): 2 Hours Postdose |
27.1
(9.15)
|
Day 2 (L/C): 4 Hours Postdose |
31.1
(9.65)
|
Day 2 (L/C): 8 Hours Postdose |
35.1
(11.37)
|
Day 2 (L/C): 12 Hours Postdose |
36.1
(11.07)
|
Day 3 (L/C): 2 Hours Postdose |
26.5
(10.95)
|
Day 3 (L/C): 4 Hours Postdose |
29.0
(10.95)
|
Day 3 (L/C): 8 Hours Postdose |
35.2
(10.76)
|
Day 3 (L/C): 12 Hours Postdose |
36.2
(11.29)
|
Day 4 (SAGE-217): 2 Hours Postdose |
35.7
(14.57)
|
Day 4 (SAGE-217): 4 Hours Postdose |
30.9
(12.84)
|
Day 4 (SAGE-217):8 Hours Postdose |
33.4
(11.65)
|
Day 4 (SAGE-217): 12 Hours Postdose |
33.3
(13.19)
|
Day 5 (SAGE-217): 2 Hours Postdose |
33.8
(12.76)
|
Day 5 (SAGE-217): 4 Hours Postdose |
32.4
(12.69)
|
Day 5 (SAGE-217): 8 Hours Postdose |
30.9
(12.02)
|
Day 5 (SAGE-217): 12 Hours Postdose |
33.0
(12.15)
|
Day 6 (SAGE-217): 2 Hours Postdose |
31.5
(11.97)
|
Day 6 (SAGE-217): 4 Hours Postdose |
31.8
(9.66)
|
Day 6 (SAGE-217): 8 Hours Postdose |
32.7
(12.81)
|
Day 6 (SAGE-217): 12 Hours Postdose |
34.5
(11.19)
|
Day 7 (SAGE-217): 2 Hours Postdose |
36.4
(12.55)
|
Day 7 (SAGE-217): 4 Hours Postdose |
35.8
(11.92)
|
Day 7 (SAGE-217): 8 Hours Postdose |
36.0
(11.73)
|
Day 7 (SAGE-217): 12 Hours Postdose |
35.6
(11.03)
|
Day 8 (Follow-up) |
35.4
(10.54)
|
Day 14 (Follow-up) |
30.2
(13.00)
|
Title | CFB in the MDS-UPDRS Part III Total Score - Part B |
---|---|
Description | Part III of the MDS-UPDRS assessed 18 motor categories, some of which included right and left measurements: speech, facial expression, kinetic tremor of hands, rest tremor amplitude, postural tremor of hands, rigidity of neck and 4 extremities, finger taps, hand movement, pronation/supination, toe tapping, constancy of rest tremor, leg agility, arising from chair, posture, gait, freezing of gait, postural stability, global spontaneity of movement. Part III total score was calculated as the sum of the individual item scores from these categories. Each item was rated from 0 (normal) to 4 (severe). The total score range for Part III is 0 to 132. Lower scores represent less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
52.4
(12.00)
|
CFB at Dose 1 (SAGE-217): 12 Hours Postdose |
-8.4
(8.74)
|
CFB at Dose 1 (SAGE-217): 23 Hours Postdose |
-10.8
(9.90)
|
CFB at Dose 2 (SAGE-217): 12 Hours Postdose |
-11.6
(12.83)
|
CFB at Dose 2 (SAGE-217): 23 Hours Postdose |
-13.5
(7.87)
|
CFB at Dose 3 (SAGE-217): 12 Hours Postdose |
-12.4
(10.51)
|
CFB at Dose 3 (SAGE-217): 23 Hours Postdose |
-10.9
(9.39)
|
CFB at Dose 4 (SAGE-217): 12 Hours Postdose |
-14.3
(12.25)
|
CFB at Dose 4 (SAGE-217): 23 Hours Postdose |
-14.8
(10.30)
|
CFB at Dose 5 (SAGE-217): 12 Hours Postdose |
-14.5
(15.52)
|
CFB at Dose 5 (SAGE-217): 23 Hours Postdose |
-18.1
(10.10)
|
CFB at Dose 6 (SAGE-217): 12 Hours Postdose |
-14.8
(11.81)
|
CFB at Dose 6 (SAGE-217): 23 Hours Postdose |
-19.5
(9.30)
|
CFB at Dose 7 (SAGE-217): 12 Hours Postdose |
-18.6
(9.51)
|
CFB at Day 14 (Follow-up) |
-14.5
(10.54)
|
Title | CFB in the MDS-UPDRS Part I Total Score - Part B |
---|---|
Description | Part I of the MDS-UPDRS assessed 13 nonmotor experiences of daily living categories. Part I total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Baseline, Day 7 (12 hours postdose), Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
9.9
(6.33)
|
CFB at Dose 7 (SAGE-217): 12 Hours Postdose |
-4.7
(6.54)
|
CFB at Day 14 (Follow-up) |
-3.9
(6.05)
|
Title | CFB in the MDS-UPDRS Part II Total Score - Part B |
---|---|
Description | Part II of the MDS-UPDRS assessed 13 categories of motor experiences of daily living: speech, salivation and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed, car, or deep chair, walking and balance, and freezing. The Part II total score was calculated as the sum of the individual item scores from these categories. The total score range for Part II is 0 to 52. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Baseline, Days 1 to 6 (12 and 23 hours postdose), Day 7 (12 hours postdose), Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
15.1
(8.26)
|
CFB at Dose 1 (SAGE-217): 12 Hours Postdose |
-1.9
(3.46)
|
CFB at Dose 1 (SAGE-217): 23 Hours Postdose |
-1.7
(3.73)
|
CFB at Dose 2 (SAGE-217): 12 Hours Postdose |
-2.1
(5.17)
|
CFB at Dose 2 (SAGE-217): 23 Hours Postdose |
-2.2
(4.92)
|
CFB at Dose 3 (SAGE-217): 12 Hours Postdose |
-2.0
(5.48)
|
CFB at Dose 3 (SAGE-217): 23 Hours Postdose |
-3.1
(4.20)
|
CFB at Dose 4 (SAGE-217): 12 Hours Postdose |
-3.4
(6.33)
|
CFB at Dose 4 (SAGE-217): 23 Hours Postdose |
-2.4
(5.43)
|
CFB at Dose 5 (SAGE-217): 12 Hours Postdose |
-4.6
(5.71)
|
CFB at Dose 5 (SAGE-217): 23 Hours Postdose |
-2.9
(4.90)
|
CFB at Dose 6 (SAGE-217): 12 Hours Postdose |
-2.9
(5.05)
|
CFB at Dose 6 (SAGE-217): 23 Hours Postdose |
-3.9
(5.40)
|
CFB at Dose 7 (SAGE-217): 12 Hours Postdose |
-3.9
(4.34)
|
CFB at Day 14 (Follow-up) |
-3.9
(5.02)
|
Title | CFB in the MDS-UPDRS Part I-IV Total Score - Part B |
---|---|
Description | The MDS-UPDRS assesses nonmotor experiences, motor experiences, motor skills, and motor complication categories. The MDS-UPDRS Part I-IV total score was calculated as the sum of the individual item scores from these categories. The total score range for Part I-IV is 0 to 260. Lower scores indicate less symptom severity. A negative change from baseline indicates an improvement in symptom severity. Baseline is the last measurement taken before the first dose of study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Baseline, Day 7 (12 hours postdose), Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy population included all participants in the safety population who received at least one dose of study drug and had at least one postdose MDS-UPDRS evaluation. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
84.6
(24.01)
|
CFB at Dose 7 (SAGE-217): 12 Hours Postdose |
-30.0
(17.71)
|
CFB at Day 14 (Follow-up) |
-24.1
(20.75)
|
Title | Percentage of Participants With TEAEs - Part B |
---|---|
Description | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was as an AE that occurred after the first administration of study drug. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 | Part B: Follow-up |
---|---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. | Participants received antiparkinsonian agent(s) at normally prescribed dosing schedule for Days 8 to 14. |
Measure Participants | 14 | 14 |
Number [percentage of participants] |
57.1
380.7%
|
0
0%
|
Title | Percentage of Participants With TEAEs, Graded by Severity - Part B |
---|---|
Description | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 | Part B: Follow-up |
---|---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. | Participants received antiparkinsonian agent(s) at normally prescribed dosing schedule for Days 8 to 14. |
Measure Participants | 14 | 14 |
Mild |
42.9
286%
|
0
0%
|
Moderate |
14.3
95.3%
|
0
0%
|
Severe |
0
0%
|
0
0%
|
Title | CFB in Basophils - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
0.06
(0.074)
|
CFB at Dose 4 (SAGE-217): Predose |
0.02
(0.089)
|
CFB at Dose 6 (SAGE-217): Predose |
0.02
(0.058)
|
CFB at Day 8 (Follow-up) |
-0.03
(0.061)
|
CFB at Day 14 (Follow-up) |
0.00
(0.055)
|
Title | CFB in Basophils to Leukocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
1.0
(0.39)
|
CFB at Dose 4 (SAGE-217): Predose |
0.2
(0.97)
|
CFB at Dose 6 (SAGE-217): Predose |
0.1
(1.00)
|
CFB at Day 8 (Follow-up) |
-0.1
(0.47)
|
CFB at Day 14 (Follow-up) |
0.1
(0.73)
|
Title | CFB in Eosinophils - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
0.12
(0.058)
|
CFB at Dose 4 (SAGE-217): Predose |
0.05
(0.065)
|
CFB at Dose 6 (SAGE-217): Predose |
0.03
(0.083)
|
CFB at Day 8 (Follow-up) |
0.03
(0.114)
|
CFB at Day 14 (Follow-up) |
-0.02
(0.058)
|
Title | CFB in Eosinophils to Leukocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
2.0
(1.04)
|
CFB at Dose 4 (SAGE-217): Predose |
0.7
(1.20)
|
CFB at Dose 6 (SAGE-217): Predose |
0.1
(0.95)
|
CFB at Day 8 (Follow-up) |
0.4
(2.06)
|
CFB at Day 14 (Follow-up) |
-0.4
(0.93)
|
Title | CFB in Erythrocytes - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
4.65
(0.335)
|
CFB at Dose 4 (SAGE-217): Predose |
0.16
(0.798)
|
CFB at Dose 6 (SAGE-217): Predose |
-0.11
(0.186)
|
CFB at Day 8 (Follow-up) |
-0.02
(0.208)
|
CFB at Day 14 (Follow-up) |
-0.06
(0.101)
|
Title | CFB in Hematocrit - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
0.436
(0.0357)
|
CFB at Dose 4 (SAGE-217): Predose |
0.023
(0.0775)
|
CFB at Dose 6 (SAGE-217): Predose |
-0.011
(0.0182)
|
CFB at Day 8 (Follow-up) |
0.006
(0.0268)
|
CFB at Day 14 (Follow-up) |
-0.002
(0.0119)
|
Title | CFB in Hemoglobin - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
140.1
(14.22)
|
CFB at Dose 4 (SAGE-217): Predose |
4.9
(20.90)
|
CFB at Dose 6 (SAGE-217): Predose |
-1.4
(5.32)
|
CFB at Day 8 (Follow-up) |
1.8
(6.03)
|
CFB at Day 14 (Follow-up) |
-0.7
(4.48)
|
Title | CFB in Leukocytes - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
6.47
(1.322)
|
CFB at Dose 4 (SAGE-217): Predose |
0.85
(2.677)
|
CFB at Dose 6 (SAGE-217): Predose |
0.31
(1.370)
|
CFB at Day 8 (Follow-up) |
-0.21
(0.935)
|
CFB at Day 14 (Follow-up) |
0.29
(1.287)
|
Title | CFB in Lymphocytes - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
1.68
(0.549)
|
CFB at Dose 4 (SAGE-217): Predose |
0.44
(0.857)
|
CFB at Dose 6 (SAGE-217): Predose |
0.26
(0.386)
|
CFB at Day 8 (Follow-up) |
0.18
(0.283)
|
CFB at Day 14 (Follow-up) |
0.11
(0.373)
|
Title | CFB in Lymphocytes to Leukocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
26.0
(6.31)
|
CFB at Dose 4 (SAGE-217): Predose |
2.5
(6.15)
|
CFB at Dose 6 (SAGE-217): Predose |
2.6
(5.34)
|
CFB at Day 8 (Follow-up) |
3.4
(5.57)
|
CFB at Day 14 (Follow-up) |
0.6
(5.73)
|
Title | CFB in Monocytes - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
0.40
(0.096)
|
CFB at Dose 4 (SAGE-217): Predose |
0.09
(0.194)
|
CFB at Dose 6 (SAGE-217): Predose |
0.03
(0.083)
|
CFB at Day 8 (Follow-up) |
0.03
(0.133)
|
CFB at Day 14 (Follow-up) |
0.01
(0.110)
|
Title | CFB in Monocytes to Leukocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
6.4
(1.55)
|
CFB at Dose 4 (SAGE-217): Predose |
0.3
(1.68)
|
CFB at Dose 6 (SAGE-217): Predose |
0.1
(1.49)
|
CFB at Day 8 (Follow-up) |
0.4
(1.74)
|
CFB at Day 14 (Follow-up) |
-0.1
(1.07)
|
Title | CFB in Neutrophils - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
4.23
(0.957)
|
CFB at Dose 4 (SAGE-217): Predose |
0.23
(1.842)
|
CFB at Dose 6 (SAGE-217): Predose |
0.00
(1.136)
|
CFB at Day 8 (Follow-up) |
-0.43
(0.902)
|
CFB at Day 14 (Follow-up) |
0.16
(1.153)
|
Title | CFB in Neutrophils to Leukocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
65.3
(5.28)
|
CFB at Dose 4 (SAGE-217): Predose |
-4.2
(7.50)
|
CFB at Dose 6 (SAGE-217): Predose |
-3.0
(6.64)
|
CFB at Day 8 (Follow-up) |
-4.4
(6.69)
|
CFB at Day 14 (Follow-up) |
-0.4
(6.69)
|
Title | CFB in Platelets - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
189.2
(37.72)
|
CFB at Dose 4 (SAGE-217): Predose |
24.1
(67.75)
|
CFB at Dose 6 (SAGE-217): Predose |
5.9
(13.64)
|
CFB at Day 8 (Follow-up) |
0.8
(20.01)
|
CFB at Day 14 (Follow-up) |
5.3
(19.58)
|
Title | CFB in Reticulocytes - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
59.3
(19.27)
|
CFB at Dose 4 (SAGE-217): Predose |
1.1
(11.35)
|
CFB at Dose 6 (SAGE-217): Predose |
5.1
(19.61)
|
CFB at Day 8 (Follow-up) |
2.4
(15.55)
|
CFB at Day 14 (Follow-up) |
5.1
(20.99)
|
Title | CFB in Reticulocytes to Erythrocytes Ratio (%) - Part B |
---|---|
Description | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, reticulocytes and reticulocytes to erythrocytes ratio. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
1.28
(0.417)
|
CFB at Dose 4 (SAGE-217): Predose |
0.04
(0.250)
|
CFB at Dose 6 (SAGE-217): Predose |
0.13
(0.410)
|
CFB at Day 8 (Follow-up) |
0.05
(0.334)
|
CFB at Day 14 (Follow-up) |
0.13
(0.486)
|
Title | CFB in Activated Partial Thromboplastin Time - Part B |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
25.05
|
CFB at Dose 4 (SAGE-217): Predose |
-0.40
|
CFB at Dose 6 (SAGE-217): Predose |
-0.05
|
CFB at Day 8 (Follow-up) |
-0.30
|
CFB at Day 14 (Follow-up) |
-0.20
|
Title | CFB in Prothrombin International Normalized Ratio - Part B |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
0.98
(0.043)
|
CFB at Dose 4 (SAGE-217): Predose |
-0.03
(0.045)
|
CFB at Dose 6 (SAGE-217): Predose |
-0.01
(0.051)
|
CFB at Day 8 (Follow-up) |
0.00
(0.041)
|
CFB at Day 14 (Follow-up) |
0.01
(0.036)
|
Title | CFB in Prothrombin Time - Part B |
---|---|
Description | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio and prothrombin time. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
10.60
|
CFB at Dose 4 (SAGE-217): Predose |
-0.20
|
CFB at Dose 6 (SAGE-217): Predose |
-0.05
|
CFB at Day 8 (Follow-up) |
-0.10
|
CFB at Day 14 (Follow-up) |
0.10
|
Title | CFB in Alanine Aminotransferase - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
10.0
(6.66)
|
CFB at Dose 4 (SAGE-217): Predose |
0.3
(3.17)
|
CFB at Dose 6 (SAGE-217): Predose |
2.6
(5.42)
|
CFB at Day 8 (Follow-up) |
1.9
(3.79)
|
CFB at Day 14 (Follow-up) |
-0.2
(3.70)
|
Title | CFB in Albumin - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
44.2
(2.75)
|
CFB at Dose 4 (SAGE-217): Predose |
-0.2
(1.40)
|
CFB at Dose 6 (SAGE-217): Predose |
-0.6
(1.65)
|
CFB at Day 8 (Follow-up) |
0.16
(1.45)
|
CFB at Day 14 (Follow-up) |
-0.1
(1.86)
|
Title | CFB in Alkaline Phosphatase - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
84.0
(22.05)
|
CFB at Dose 4 (SAGE-217): Predose |
1.4
(7.55)
|
CFB at Dose 6 (SAGE-217): Predose |
2.1
(3.23)
|
CFB at Day 8 (Follow-up) |
2.2
(8.85)
|
CFB at Day 14 (Follow-up) |
-1.1
(8.69)
|
Title | CFB in Aspartate Aminotransferase - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
17.7
(10.59)
|
CFB at Dose 4 (SAGE-217): Predose |
-2.8
(10.63)
|
CFB at Dose 6 (SAGE-217): Predose |
-1.4
(10.93)
|
CFB at Day 8 (Follow-up) |
-0.4
(11.51)
|
CFB at Day 14 (Follow-up) |
-2.4
(10.12)
|
Title | CFB in Bicarbonate - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian Agent(s) + SAGE-217 |
---|---|
Arm/Group Description | Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food. |
Measure Participants | 14 |
Baseline |
24.6
(1.74)
|
CFB at Dose 4 (SAGE-217): Predose |
-1.2
(1.90)
|
CFB at Dose 6 (SAGE-217): Predose |
-0.9
(2.06)
|
CFB at Day 8 (Follow-up) |
-1.1
(2.23)
|
CFB at Day 14 (Follow-up) |
-0.3
(1.77)
|
Title | CFB in Bilirubin - Part B |
---|---|
Description | Clinical chemistry measures included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium, chloride, creatinine, lipase, magnesium, phosphate, potassium, protein, sodium, urate and urea nitrogen. Baseline is the last measurement taken before the first dose of the study drug. Doses 1 to 7 were given on Days 1 to 7, respectively. The analysis was performed in participants included in Part B of the study. |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
Analysis Population Description |
---|
The safety population included all participants who were administered study drug. Number analyzed = Number of participants with data available at the specific time point. |
Arm/Group Title | Part B: Antiparkinsonian |
---|