MitoQ for Fatigue in Multiple Sclerosis (MS)

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Ubiquinone

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