MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial

Stopped earlyPhase 1Phase 2MS (type not specified)NCT03166800

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Lack of adequate funding

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Mitoquinone cation

Placebo

  • Placebo

What it measured

Main measures

  • Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation

    Baseline to 12 weeks post drug initiation.

    Fatigue

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 2010 McDonald criteria40; * Expanded Disability Status Scale (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 (severe depression); * Significant MS exacerbation in prior 30 days; * Previous use of MitoQ or CoQ-10 within 30 days of screening appointment; * Use of non-research-pharmacy-administered MitoQ or CoQ-10 during the duration of the study; * Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events), * Pregnancy or intending to become pregnant or breastfeeding; * Unable to complete the self-report forms; * Unable to give informed consent; * Prisoners will be excluded. * 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 study drug initiation will assess if MitoQ has a significant change in fatigue.

Papers

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    History

      1. Started

        Sept 2018

      2. Main results due

        Jan 2019

      3. Finished

        Jan 2019

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