INKLING-MS: Ketamine for Multiple Sclerosis Fatigue
Study Details
Study Description
Brief Summary
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ketamine-Ketamine Participants in this arm will receive two infusions of ketamine four weeks apart. |
Drug: Ketamine
Infusion of ketamine 0.5 mg/kg over 40 minutes
|
| Experimental: Ketamine-Midazolam Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam. |
Drug: Ketamine
Infusion of ketamine 0.5 mg/kg over 40 minutes
Drug: Midazolam
Infusion of midazolam 0.05 mg/kg over 40 minutes
|
| Experimental: Midazolam-Ketamine Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine. |
Drug: Ketamine
Infusion of ketamine 0.5 mg/kg over 40 minutes
Drug: Midazolam
Infusion of midazolam 0.05 mg/kg over 40 minutes
|
Outcome Measures
Primary Outcome Measures
- Modified Fatigue Impact Scale (MFIS) Score [Baseline (infusion visit) through four weeks after the infusion.]
The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
Secondary Outcome Measures
- Fatigue Severity Scale (FSS) [Baseline (infusion visit) through four weeks after the infusion.]
The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.
- Epworth Sleepiness Scale (ESS) [Baseline (infusion visit) through four weeks after the infusion.]
The total score of the ESS ranges from 0 to 24. Higher scores denote more severe sleepiness.
- Beck Depression Inventory-II (BDI-II) [Baseline (infusion visit) through four weeks after the infusion.]
The total score of the BDI-IIranges from 0 to 63. Higher scores denote more severe depression.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject must be a man or woman, 18 to 65 years of age, inclusive.
-
Subject must be medically stable based on physical examination, medical history, and vital signs
-
Subject must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
-
Subject must complain from fatigue as one of their main symptoms and have a screening MFIS score equal or higher than the cutoff based on gender, age, and education displayed in Table-226
-
Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)
-
Subject must have internet and email access and ability to use a computer or tablet or smartphone
-
Subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at Screening are eligible to participate unless the medication is one of the disallowed therapies (Table 3). Subjects taking a fatigue medication at the Screening visit must have been receiving a stable dose for at least four weeks before the Screening visit and be willing to continue the medication at the same dose for the duration of the study.
Exclusion Criteria:
-
BDI-II score of more than 29 (indicating severe depression)
-
Having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women).
-
Neurodegenerative disorders other than relapsing or progressive MS
-
Breastfeeding or pregnant
-
History of coronary artery disease or congestive heart failure
-
Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100)
-
History of severe liver disease, including cirrhosis
-
Terminal medical conditions
-
Currently treated for active malignancy
-
Alcohol or substance abuse in the past year (except marijuana or other cannabinoids)
-
A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
-
Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI
-
History of severe or untreated coronary artery disease or history of congestive heart failure
-
History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
-
History of recurrent seizures or epilepsy
-
Taking any disallowed therapy(ies), as noted in the protocol.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Johns Hopkins University
- United States Department of Defense
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00322473