MitoQ for Fatigue in Multiple Sclerosis

NCT ID: NCT03166800

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-01-10

Brief 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 study drug initiation will assess if MitoQ has a significant change in fatigue.

Detailed Description

MitoQ is a potent antioxidant with potentially significant immunomodulatory and anti-inflammatory properties. While the cause of MS related fatigue is uncertain, the investigators believe that mitochondria dysfunction and resultant neuronal energy depletion may be an important contributor to fatigue in MS.

This clinical trial will evaluate the potential beneficial effects of MitoQ on MS fatigue. It will also explore the effects of MitoQ on cognitive function, quality of life and mood. If enrolled in the study, patients will take two capsules of the study drug or placebo at the same time every day for twelve weeks. There will be 4 study visits where the participant will undergo medical and nervous system examinations, questionnaires, and blood draws. Because it is a placebo-controlled trial, participants will have a 33% chance of receiving either placebo (inactive), 20mg of MitoQ, or 40mg of MitoQ. This will be a blinded randomized study, meaning neither the participant nor the investigator will know who received the placebo or study drug.

Conditions

Multiple Sclerosis; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

20 subjects will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

20mg oral MitoQ

MitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 20mg of MitoQ will be administered to 20 subjects in this trial.

Group Type: ACTIVE_COMPARATOR

Mitoquinone

Intervention Type: DRUG

This arm of the intervention the study subject will be administered 20mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

40mg oral MitoQ

MitoQ is a potent antioxidant supplement with potentially significant immunomodulatory and anti-inflammatory properties. 40mg of MitoQ will be administered to 20 subjects in this trial.

Group Type: ACTIVE_COMPARATOR

Mitoquinone

Intervention Type: DRUG

This arm of the intervention the study subject will be administered 40mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

Interventions

Mitoquinone

This arm of the intervention the study subject will be administered 40mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

Intervention Type: DRUG

Mitoquinone

This arm of the intervention the study subject will be administered 20mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

Intervention Type: DRUG

Placebo

This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

mitoquinol; mitoquinol

Eligibility Criteria

Inclusion Criteria

• MS (any clinical subtype) as diagnosed by the 2010 McDonald criteria40;
• Expanded Disability Status Scale (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 (severe depression);
• Significant MS exacerbation in prior 30 days;
• Previous use of MitoQ or CoQ-10 within 30 days of screening appointment;
• Use of non-research-pharmacy-administered MitoQ or CoQ-10 during the duration of the study;
• Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events),
• Pregnancy or intending to become pregnant or breastfeeding;
• Unable to complete the self-report forms;
• Unable to give informed consent;
• Prisoners will be excluded.
• Any condition which would make the patient, in the opinion of the investigator, unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MitoQ Limited

UNKNOWN

Sponsor Role: collaborator

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Vijayshree Yadav

MD, MCR, FANA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vijayshree Yadav, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

STUDY00015779

Identifier Type: -

Identifier Source: org_study_id