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Completed

NCT Number: NCT04267926

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20 mg MitoQ

Drug

a third of subject will receive 20mg of oral MitoQ

Other names: Oral Mitoquinol

Placebo

Drug

Subject will receive Placebo

40mg of MitoQ

Drug

a third of subjects will receive 40mg of MitoQ

Other names: Oral Mitoquinol

Primary outcomes

  1. Modified Fatigue Inventory Scale (MFIS)

    Time frame: Week 1, Week 7, Week 13

    MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.

Secondary outcomes

  1. Symbol Digit Modalities Test (SDMT)

    Time frame: Week 1, Week 7, Week 13

    SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome.

  2. Expanded Disability Status Scale (EDSS)

    Time frame: 12 weeks

    EDSS measures neurological function. Scale 0-10

  3. Beck's Depression Inventory (BDI)

    Time frame: 12 weeks

    BDI is a self-reported questionnaire measuring depression. Scale 0-21

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

Acronym: MitoQ

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Feb 13, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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