MitoQ for Multiple Sclerosis

(MitoQ Trial)

Overseen By Allison Fryman

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: VA Office of Research and Development

Must not be taking: Glucocorticoids, MitoQ, CoQ10

Disqualifiers: Severe depression, Coronary disease, Diabetes, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

47 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used MitoQ or CoQ10 in the 30 days before the screening. Also, you should not have been treated with systemic glucocorticoids in the six weeks before the trial.

Research Team

Vijayshree Yadav, MBBS

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

This trial is for MS patients with persistent fatigue and an MFIS score of 38 or higher. They must have been diagnosed by the McDonald criteria, have an EDSS score between 2 to 8, and not be severely depressed. People can't join if they've used steroids recently, are pregnant/breastfeeding, have certain health issues like heart or liver disease, or were on MitoQ/CoQ10 in the last month.

Inclusion Criteria

I have been feeling tired for at least two months.

I have been diagnosed with multiple sclerosis according to the 2017 criteria.

My disability score is between 2 and 8.

Exclusion Criteria

I haven't taken MitoQ or CoQ10 in the last 30 days.

You have a score higher than 31 on the Beck Depression Inventory or higher than 10 on the BDI-FS, indicating severe depression.

I do not have any major health issues that could worsen by participating in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or MitoQ (20mg or 40mg) daily for 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MitoQ

Trial Overview The study tests if MitoQ reduces fatigue in MS patients compared to a placebo. Participants will either take a daily dose of MitoQ (20mg or 40mg) or a placebo for 12 weeks. Their levels of fatigue at the start and after treatment will show if there's any improvement.

Participant Groups

Group I: 20mg of MitoQ Active Control 1 Intervention

20mg of oral mitoquinol

Group II: 40mg of MitoQ Active Control 1 Intervention

40mg of Oral Mitoquinol

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+