Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Sponsor
UCB Biopharma S.P.R.L. (Industry)
Overall Status
Completed
CT.gov ID
NCT03103919
Collaborator
(none)
40
8
2
9.6
5
0.5
Study Details
Study Description
Brief Summary
Evaluate the benefits of Kinesia-360™ wearable technology in addition to standard clinical practice on improving Parkinson´s disease motor symptoms, Neupro dosing regimen and adherence to Neupro compared with only standard clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Two-Arm Study to Evaluate the Impact of Using Wearable Devices in Addition to Standard Clinical Practice on Parkinson´s Subject Symptoms Management
Actual Study Start Date
:
Mar 16, 2017
Actual Primary Completion Date
:
Jan 2, 2018
Actual Study Completion Date
:
Jan 2, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rotigotine + Standard Care Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject will be determined by standard clinical practice. |
Device: Kinesia-ONE™
Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
Drug: Rotigotine
All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
Other Names:
|
| Experimental: Rotigotine + Standard Care + Kinesia-360™ wearable device Subjects will use the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects will use the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator will use these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
Device: Kinesia-ONE™
Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
Device: Kinesia-360™
Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.
Drug: Rotigotine
All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)]
UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score [Baseline (Visit 1/Week 1) to Visit 2 (Week 12)]
Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.
- Neupro Dose Per 24h at Visit 2 (Week 12) [Visit 2 (Week 12)]
Daily dose of study medication taken at respective visit.
- Number of Neupro Dose Changes During the Study [Visit 1 (Week 1) to Visit 2 (Week 12)]
Dose adjustments during study are performed per standard of care.
- Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study [Visit 1 (Week 1) to Visit 2 (Week 12)]
Number of subjects who discontinued Neupro Treatment were recorded.
Secondary Outcome Measures
- Number of Subjects With Any Adverse Events During the Course of the Study [Visit 1 (Week 1) to Visit 2 (Week 12)]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is newly prescribed Neupro and is expected to commence Neupro treatment. Historical Neupro treatment is permitted
-
Informed Consent form (ICF) is signed and dated by the subject, before any study-related procedures
-
Subject is considered reliable and capable of adhering to the protocol, visit schedule, completion of the diary, and using Kinesia devices according to the judgment of the Investigator
-
Male or female subject, >=18 years of age at the time of the Screening Visit
-
Subject has Parkinson's disease, defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: tremor at rest, rigidity or impairment of postural reflexes, and without any other known or suspected cause of Secondary Parkinsonism
-
Subject experiences motor symptoms associated with Parkinson's disease that are not sufficiently controlled by current therapy. The average of the triplicate resting tremor scores and triplicate finger tapping scores from Kinesia-ONE™ (6 scores in total) must be >1.0
Exclusion Criteria:
-
Subject is currently participating in any study with an investigational medicinal product or investigational device
-
Subject has any medical, neurological or psychiatric condition which, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
-
Subject with Deep Brain Stimulation (DBS) device implant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pd0049 105 | Fountain Valley | California | United States | 92708 |
| 2 | Pd0049 102 | Boca Raton | Florida | United States | 33486 |
| 3 | Pd0049 108 | Winfield | Illinois | United States | 60190 |
| 4 | Pd0049 103 | Kansas City | Kansas | United States | 66160 |
| 5 | Pd0049 106 | Commack | New York | United States | 11725 |
| 6 | Pd0049 104 | Tulsa | Oklahoma | United States | 74136 |
| 7 | Pd0049 107 | Greenville | South Carolina | United States | 29615 |
| 8 | Pd0049 109 | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- UCB Biopharma S.P.R.L.
Investigators
- Study Director: UCB Cares, +1 844 599 2273 (UCB)
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:
NCT03103919
Other Study ID Numbers:
- PD0049
First Posted:
Apr 6, 2017
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by UCB Biopharma S.P.R.L.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study started to enroll patients in March 2017 and concluded in January 2018. |
|---|---|
| Pre-assignment Detail | Participant Flow refers to the Safety Set (SS), which consists of all subjects who received at least 1 dose of Neupro. One subject who received Neupro after screen failing was not considered as treated within the study and, therefore, not included in the SS. |
| Arm/Group Title | Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Period Title: Overall Study | ||
| STARTED | 20 | 19 |
| COMPLETED | 18 | 17 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | Total Title |
|---|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. | |
| Overall Participants | 20 | 19 | 39 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
25%
|
5
26.3%
|
10
25.6%
|
| >=65 years |
15
75%
|
14
73.7%
|
29
74.4%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69.76
(7.16)
|
67.62
(9.77)
|
68.72
(8.49)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
60%
|
10
52.6%
|
22
56.4%
|
| Male |
8
40%
|
9
47.4%
|
17
43.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian |
2
10%
|
0
0%
|
2
5.1%
|
| White |
17
85%
|
19
100%
|
36
92.3%
|
| Other/mixed |
1
5%
|
0
0%
|
1
2.6%
|
Outcome Measures
| Title | Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score |
|---|---|
| Description | UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 20 | 19 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-1.0
(2.1)
|
-5.3
(2.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.134 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.31 | |
| Confidence Interval |
(2-Sided) 95% -10.04 to 1.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on scale] |
-0.394
(0.160)
|
-0.389
(0.167)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.982 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.495
(0.231)
|
-0.674
(0.238)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.566 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to 0.45 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.450
(0.156)
|
-0.525
(0.156)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.720 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.489
(0.141)
|
-0.342
(0.143)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.443 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
0.083
(0.242)
|
-0.009
(0.238)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.777 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to 0.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.178
(0.115)
|
-0.188
(0.117)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.947 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
0.119
(0.190)
|
-0.147
(0.188)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.306 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to 0.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.202
(0.102)
|
-0.171
(0.106)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.819 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS). | |
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
-0.240
(0.123)
|
-0.167
(0.122)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.663 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score |
|---|---|
| Description | Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. |
| Time Frame | Baseline (Visit 1/Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 19 | 18 |
| Least Squares Mean (Standard Error) [Scores on a scale] |
0.125
(0.108)
|
-0.074
(0.112)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.197 |
| Comments | ||
| Method | ANCOVA | |
| Comments | The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Neupro Dose Per 24h at Visit 2 (Week 12) |
|---|---|
| Description | Daily dose of study medication taken at respective visit. |
| Time Frame | Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post-Baseline efficacy measurement. |
| Arm/Group Title | Rotigotine + Standard Care FAS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 16 | 16 |
| Mean (Standard Deviation) [mg/24 hr] |
3.9
(1.7)
|
4.8
(1.8)
|
| Title | Number of Neupro Dose Changes During the Study |
|---|---|
| Description | Dose adjustments during study are performed per standard of care. |
| Time Frame | Visit 1 (Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. |
| Arm/Group Title | Rotigotine + Standard Care SS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 20 | 19 |
| Mean (Standard Deviation) [dose changes] |
1.8
(1.2)
|
2.8
(1.7)
|
| Title | Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study |
|---|---|
| Description | Number of subjects who discontinued Neupro Treatment were recorded. |
| Time Frame | Visit 1 (Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. |
| Arm/Group Title | Rotigotine + Standard Care SS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 20 | 19 |
| Count of Participants [Participants] |
5
25%
|
5
26.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Rotigotine + Standard Care FAS, Rotigotine + Standard Care + Kinesia-360™ Wearable Device FAS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | =0.876 |
| Comments | P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.14 | |
| Confidence Interval |
(2-Sided) 95% 0.23 to 5.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center. | |
| Title | Number of Subjects With Any Adverse Events During the Course of the Study |
|---|---|
| Description | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Time Frame | Visit 1 (Week 1) to Visit 2 (Week 12) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Set (SS) included all subjects who received at least 1 dose of Neupro. |
| Arm/Group Title | Rotigotine + Standard Care SS | Rotigotine + Standard Care + Kinesia-360™ Wearable Device SS |
|---|---|---|
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. |
| Measure Participants | 20 | 19 |
| Count of Participants [Participants] |
9
45%
|
11
57.9%
|
Adverse Events
| Time Frame | From Visit 1 (Day 1) to Visit 2 (Week 12) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | ||
| Arm/Group Description | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms. The optimal dose of Neupro for any given subject was determined by standard clinical practice. | Subjects used the Kinesia-ONE™ wearable device in-clinic at Visit 1 and Visit 2 for recording of specific motor symptoms, and additionally subjects used the Kinesia-360™ wearable device at home while awake for continuous measurement of motor symptoms. The Investigator used these symptom data to provide feedback to subjects on their motor symptoms and to supplement standard of care to titrate the optimal dose of Neupro for any given subject. | ||
All Cause Mortality |
||||
| Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/19 (0%) | ||
Serious Adverse Events |
||||
| Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/20 (5%) | 1/19 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Small intestinal obstruction | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal impairment | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Rotigotine + Standard Care | Rotigotine + Standard Care + Kinesia-360™ Wearable Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/20 (45%) | 10/19 (52.6%) | ||
| Eye disorders | ||||
| Vision blurred | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Abdominal distension | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Constipation | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Abdominal discomfort | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Nausea | 3/20 (15%) | 3 | 2/19 (10.5%) | 2 |
| Vomiting | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| General disorders | ||||
| Application site pruritus | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Fatigue | 1/20 (5%) | 1 | 3/19 (15.8%) | 3 |
| Asthenia | 0/20 (0%) | 0 | 2/19 (10.5%) | 2 |
| Feeling abnormal | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Chest discomfort | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Investigations | ||||
| Weight increased | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Nervous system disorders | ||||
| Somnolence | 3/20 (15%) | 3 | 4/19 (21.1%) | 5 |
| Headache | 1/20 (5%) | 1 | 1/19 (5.3%) | 1 |
| Dizziness | 1/20 (5%) | 1 | 2/19 (10.5%) | 2 |
| Psychiatric disorders | ||||
| Binge eating | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Hallucination, visual | 1/20 (5%) | 1 | 1/19 (5.3%) | 1 |
| Hallucination, auditory | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Sleep disorder | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/20 (5%) | 1 | 1/19 (5.3%) | 1 |
| Vascular disorders | ||||
| Hot flush | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | UCB |
|---|---|
| Organization | Cares |
| Phone | +1844 599 ext 2273 |
| UCBCares@ucb.com |
Responsible Party:
UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier:
NCT03103919
Other Study ID Numbers:
- PD0049
First Posted:
Apr 6, 2017
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019