Phase 2 Completed N=45 Randomized Double-blind Treatment

MitoQ for Fatigue in Multiple Sclerosis (MS)

Source: ClinicalTrials.gov NCT04267926 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcomePrimary: Modified Fatigue Inventory Scale (MFIS) — 46.5; 55.2; 54.3; 45.1 units on a scale — p=0.9489

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.

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)	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.