MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

CompletedPhase 1Phase 2MS (type not specified)NCT04267926

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Modified Fatigue Inventory Scale (MFIS) 0.9489

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Mitoquinone cation

Placebo

  • Placebo

Results by group

Modified Fatigue Inventory Scale (MFIS)

Week 1, Week 7, Week 13

GroupValueIntervalNumber analysed
Placebo46.5 units on a scale2.8 (Standard Error)16
20mg of MitoQ55.2 units on a scale2.8 (Standard Error)15
40mg of MitoQ54.3 units on a scale2.9 (Standard Error)14
Placebo45.1 units on a scale3.1 (Standard Error)16
20mg of MitoQ50.5 units on a scale2.9 (Standard Error)15
40mg of MitoQ49 units on a scale3.1 (Standard Error)14
Placebo39.7 units on a scale2.8 (Standard Error)16
20mg of MitoQ48.7 units on a scale2.8 (Standard Error)15
40mg of MitoQ47.8 units on a scale3 (Standard Error)14

p = 0.9489

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo160 (0.0%)0
20mg of MitoQ150 (0.0%)0
40mg of MitoQ140 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Modified Fatigue Inventory Scale (MFIS)

    Week 1, Week 7, Week 13

    Fatigue

Other measures (3)

  • Symbol Digit Modalities Test (SDMT)

    Week 1, Week 7, Week 13

    Thinking and memory
  • Expanded Disability Status Scale (EDSS)

    12 weeks

    Disability progression
  • Beck's Depression Inventory (BDI)

    12 weeks

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 70 · EDSS 2 to 8

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Apr 2020

      2. Main results due

        Oct 2024

      3. Finished

        Mar 2026

      4. Results posted

        Oct 2025

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