MitoQ for Fatigue in Multiple Sclerosis (MS)

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Feb 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called mitoquinone (MitoQ) can help reduce fatigue in people with Multiple Sclerosis (MS). Fatigue is a common and challenging symptom for many individuals with MS, and this study aims to see if taking MitoQ can lead to less fatigue compared to a placebo, which is a harmless pill that looks like the real medication but doesn’t contain any active ingredients. Participants will be asked to rate their fatigue levels at the beginning of the study and again after 12 weeks to see if there is a meaningful improvement.

To be eligible for this trial, participants must have a diagnosis of MS and have experienced fatigue for at least two months. They should also have a specific score on a fatigue assessment tool. The trial is open to adults aged 18 to 65, regardless of gender. However, individuals with certain health issues, severe depression, or who are pregnant or breastfeeding cannot participate. Those who join the study will receive either MitoQ or a placebo for 12 weeks and will help researchers understand if MitoQ can make a positive difference in managing fatigue for MS patients.

Gender

ALL

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