MitoQ for Fatigue in Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.

Detailed Description
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Recruitment of subjects on hold due to COVID-19 pandemic MitoQ is a potent antioxidant dietary supplement with potentially significant immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in MS. This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It will also explore the effects of MitoQ on cognitive function, quality of life and mood. If enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. There will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. Because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.

Official Title
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MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

Conditions
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Multiple Sclerosis, Fatigue

Intervention / Treatment
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* Drug: 20 mg MitoQ
* Drug: Placebo
* Drug: 40mg of MitoQ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS (any clinical subtype) as diagnosed by the 2017 McDonald criteria EDSS score of 2 to 8 complaint of fatigue that has been persistent for at least two months Modified Fatigue Impact Scale (MFIS) score of 38 or greater Exclusion Criteria: treatment with systemic glucocorticoids in the prior six weeks Beck Depression Inventory (BDI) >31 or BDI-FS>10 (severe depression) significant MS exacerbation in prior 30 days previous use of MitoQ or Coenzyme Q10 (CoQ10) within thirty days of screening appointment other significant health problem that might increase risk of patient experiencing Adverse Events (AEs), e.g.: active coronary heart disease liver disease pulmonary disease diabetes mellitus pregnancy or intending to become pregnant or breastfeeding unable to complete the self-report forms unable to give informed consent prisoners any condition which would make the patient in the opinion of the investigator unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Interventional Model Description: Double-blind, randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Subject will receive Placebo<br>|
| Active Comparator: 20mg of MitoQ<br>20mg of oral mitoquinol | Drug: 20 mg MitoQ<br>* a third of subject will receive 20mg of oral MitoQ<br>* Other names: Oral Mitoquinol;|
| Active Comparator: 40mg of MitoQ<br>40mg of Oral Mitoquinol | Drug: 40mg of MitoQ<br>* a third of subjects will receive 40mg of MitoQ<br>* Other names: Oral Mitoquinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Inventory Scale (MFIS) | MFIS is a self -reported fatigue survey. Scale 0 - 84 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symbol Digit Modalities Test (SDMT) | SDMT measures cognitive function. Scale 0-110 | 12 weeks | 
| Expanded Disability Status Scale (EDSS) | EDSS measures neurological function. Scale 0-10 | 12 weeks | 
| Beck's Depression Inventory (BDI) | BDI is a self-reported questionnaire measuring depression. Scale 0-21 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Fatigue, Mitochondrial