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Mitochondrial-targeted antioxidant

MitoQ for Multiple Sclerosis (MitoQ Trial)

Phase 1 & 2
Recruiting
Led By Vijayshree Yadav, MBBS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complaint of fatigue that has been persistent for at least two months
MS (any clinical subtype) as diagnosed by the 2017 McDonald criteria
Must not have
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
Significant MS exacerbation in prior 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial will test if a drug called MitoQ can help reduce fatigue in MS patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects aren't specified here but generally could include digestive discomforts, headaches, dizziness, skin reactions or other symptoms depending on how individuals react to MitoQ.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been feeling tired for at least two months.
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I have been diagnosed with multiple sclerosis according to the 2017 criteria.
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My disability score is between 2 and 8.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health issues that could worsen by participating in this study.
Select...
I have had a major MS flare-up in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Modified Fatigue Inventory Scale (MFIS)
Secondary study objectives
Beck's Depression Inventory (BDI)
Expanded Disability Status Scale (EDSS)
Symbol Digit Modalities Test (SDMT)

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 20mg of MitoQActive Control1 Intervention
20mg of oral mitoquinol
Group II: 40mg of MitoQActive Control1 Intervention
40mg of Oral Mitoquinol
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,748 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
1,144 Patients Enrolled for Multiple Sclerosis
Vijayshree Yadav, MBBSPrincipal InvestigatorVA Portland Health Care System, Portland, OR

Media Library

MitoQ (Mitochondrial-targeted antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT04267926 — Phase 1 & 2
Multiple Sclerosis Research Study Groups: Placebo, 20mg of MitoQ, 40mg of MitoQ
Multiple Sclerosis Clinical Trial 2023: MitoQ Highlights & Side Effects. Trial Name: NCT04267926 — Phase 1 & 2
MitoQ (Mitochondrial-targeted antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267926 — Phase 1 & 2
~11 spots leftby Nov 2025
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