Clinical trial NCT04267926: MitoQ for Fatigue in Multiple Sclerosis (MS)
Official title: MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Fatigue
Keywords: Multiple Sclerosis
Fatigue
Mitochondrial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-02-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Fatigue Inventory Scale (MFIS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 12 weeks
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 12 weeks
measure: Beck's Depression Inventory (BDI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Vijayshree Yadav, MBBS
role: PRINCIPAL_INVESTIGATOR
References: