Multiple SclerosisPhase 1/2MitoQNCT04267926
MitoQ for Fatigue in Multiple Sclerosis (MS)
A Phase 1/2 study testing 20 mg MitoQ and 40mg of MitoQ in people with Multiple Sclerosis and Fatigue, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- 20 mg MitoQ and 40mg of MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 31 Mar 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
About this study
Official title: MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- 20 mg MitoQ, Placebo, 40mg of MitoQ
- Keywords
- Multiple Sclerosis, Fatigue, Mitochondrial
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg MitoQDrug
Also called Oral Mitoquinol
a third of subject will receive 20mg of oral MitoQ
PlaceboDrug
Subject will receive Placebo
40mg of MitoQDrug
Also called Oral Mitoquinol
a third of subjects will receive 40mg of MitoQ
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| 20mg of MitoQ | Active comparator | 20mg of oral mitoquinol Receives: Drug: 20 mg MitoQ |
| 40mg of MitoQ | Active comparator | 40mg of Oral Mitoquinol Receives: Drug: 40mg of MitoQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Inventory Scale (MFIS)
MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.
Measured: Week 1, Week 7, Week 13
Secondary outcomes (3)
Symbol Digit Modalities Test (SDMT)
SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome.
Measured: Week 1, Week 7, Week 13
Expanded Disability Status Scale (EDSS)
EDSS measures neurological function. Scale 0-10
Measured: 12 weeks
Beck's Depression Inventory (BDI)
BDI is a self-reported questionnaire measuring depression. Scale 0-21
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Apr 2020
- Primary completion15 Oct 2024
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Vijayshree Yadav, MBBS, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267926
- Sponsor's protocol ID
- NURB-022-19S
- Other IDs
- 4337
- Acronym
- MitoQ
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2020
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No