Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2020-04-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
Subject will receive Placebo
20mg of MitoQ
20mg of oral mitoquinol
20 mg MitoQ
a third of subject will receive 20mg of oral MitoQ
40mg of MitoQ
40mg of Oral Mitoquinol
40mg of MitoQ
a third of subjects will receive 40mg of MitoQ
Interventions
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20 mg MitoQ
a third of subject will receive 20mg of oral MitoQ
Placebo
Subject will receive Placebo
40mg of MitoQ
a third of subjects will receive 40mg of MitoQ
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Vijayshree Yadav, MBBS
Role: PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR
Locations
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VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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4337
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NURB-022-19S
Identifier Type: -
Identifier Source: org_study_id