Ketamine for MS Fatigue

Study Overview
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Brief Summary
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The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. We propose a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.

Detailed Description
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The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group. After their first infusion cycle, they will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

Official Title
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A PILOT STUDY OF INTRAVENOUS, SUBANESTHETIC DOSE OF KETAMINE VS PLACEBO, A CROSSOVER DESIGN, FOR MULTIPLE SCLEROSIS RELATED FATIGUE

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and Male patients with any form of CDMS ages 18-65 inclusive Report fatigue which is interfering with QOL Able and willing to sign informed consent Stable on DMT for at least 3 months prior to baseline visit Not experiencing an MS relapse within 90 days prior to baseline visit. Must agree to practice an acceptable method of contraception Experiencing significant fatigue due to MS (MFIS of ≥10) Exclusion Criteria: Allergy to Ketamine Taking medications which may interact with ketamine Change in DMT within 3 months prior to baseline visit MS relapse within 90 days of the baseline visit Confirmed diagnosis of untreated Sleep Apnea Confirmed diagnosis of periodic limb movement disorder Serious infection in the 30 days prior to baseline visit. Patients with significant comorbid conditions: Untreated hypertension (SBP>160, DBP>100 at baseline) Liver disease Significant renal disease History of cardiac arrhythmia Any comorbidities which at the opinion of the investigators post undue risk Current alcohol or drug abuse Participation in another interventional clinical trial in the past 3 months. Pregnant or lactating Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine (active treatment)<br>dose of 0.5 mg/kg intravenously over 40 minutes on day 1 | Drug: ketamine<br>* 60mg (.5mg/kg over 40 minutes intravenously)<br>* Other names: Ketalar;|
| Placebo Comparator: Saline (placebo treatment)<br>Placebo (saline solution) over 40 minutes on day 1 | Drug: ketamine<br>* 60mg (.5mg/kg over 40 minutes intravenously)<br>* Other names: Ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve Fatigue Scores | a statistically significant change in the level of fatigue score as measured by the MS fatigue scales between baseline and day 28 post study drug infusion | 28 days post study drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve Quality of Life | A statistically significant change in the patient's quality of life as measured by FILMS between baseline and day 28 | Between baseline and day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS related Fatigue