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MitoQ for Fatigue in Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166800
Recruitment Status : Terminated (Lack of adequate funding)
First Posted : May 25, 2017
Last Update Posted : April 5, 2023
Sponsor:
Collaborators:
MitoQ Limited
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Fatigue Drug: Mitoquinone Drug: Placebo Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 15, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
20 subjects will receive placebo.
 Drug: Placebo
This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.
Active Comparator: 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.
 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.
Other Name: mitoquinol
Active Comparator: 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.
 Drug: 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.
Other Name: mitoquinol


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166800


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
MitoQ Limited
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Vijayshree Yadav, MD Oregon Health and Science University
More Information
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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    Key Record Dates
Last Update Posted: April 5, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vijayshree Yadav, Oregon Health and Science University:
mitoquinone
Fatigue
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ubiquinone
Micronutrients
Physiological Effects of Drugs