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MS: MitoQ for Fatigue in Multiple Sclerosis

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT03166800
Collaborator
MitoQ Ltd (Other)
9
Enrollment
1
Location
3
Arms
13.7
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

MitoQ is a potent antioxidant dietary supplement 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
Actual Study Start Date :
Sep 15, 2018
Actual Primary Completion Date :
Nov 5, 2019
Actual Study Completion Date :
Nov 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

20 subjects will receive placebo.

Drug: Mitoquinone
MitoQ will administered in either 20mg or 40mg capsules. The dose will administered for a 12-weeks treatment.
Other Names:
  • mitoquinol

    		•
    Active Comparator: 20mg oral MitoQ

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

    Drug: Mitoquinone
    MitoQ will administered in either 20mg or 40mg capsules. The dose will administered for a 12-weeks treatment.
    Other Names:
  • mitoquinol

    		•
    Active Comparator: 40mg oral MitoQ

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

    Drug: Mitoquinone
    MitoQ will administered in either 20mg or 40mg capsules. The dose will administered for a 12-weeks treatment.
    Other Names:
  • mitoquinol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation [Baseline to 12 weeks post drug initiation.]

      This primary outcome measure will be the difference from baseline in fatigue scores as measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • MitoQ Ltd

    Investigators

    • Principal Investigator: Vijayshree Yadav, MD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vijayshree Yadav, MD, MCR, FANA, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03166800
    Other Study ID Numbers:
    • STUDY00015779
    First Posted:
    May 25, 2017
    Last Update Posted:
    Apr 10, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vijayshree Yadav, MD, MCR, FANA, Oregon Health and Science University
    mitoquinone
    Fatigue
    Multiple Sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Fatigue

    Study Results

    No Results Posted as of Apr 10, 2020