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MitoQ for Fatigue in Multiple Sclerosis (MS)

CompletedPhase 1, Phase 2

Sponsor: VA Office of Research and Development

Conditions: Multiple Sclerosis, Fatigue

Interventions: 20 mg MitoQ, Placebo, 40mg of MitoQ

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Portland, Oregon, United States