Phase 2
N=45
MitoQ for Fatigue in Multiple Sclerosis (MS)
Multiple Sclerosis · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT04267926 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Modified Fatigue Inventory Scale (MFIS) — 46.5; 55.2; 54.3; 45.1 units on a scale — p=0.9489
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 20 mg MitoQ (Drug); Placebo (Drug); 40mg of MitoQ (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Fatigue Inventory Scale (MFIS) |
46.5; 55.2; 54.3; 45.1; 50.5; 49 | 0.9489 |
| SECONDARY Symbol Digit Modalities Test (SDMT) |
31.3; 25.9; 33.3; 33.2; 28.8; 36.1 | — |
| SECONDARY Expanded Disability Status Scale (EDSS) |
— | — |
| SECONDARY Beck's Depression Inventory (BDI) |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04267926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.