Multiple Sclerosis Clinical Trial
MitoQ for Fatigue in Multiple Sclerosis (MS)
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.
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.
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
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
pregnancy or intending to become pregnant or breastfeeding
unable to complete the self-report forms
unable to give informed consent
any condition which would make the patient in the opinion of the investigator unsuitable for the study
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.