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MitoQ for Fatigue in Multiple Sclerosis (MS) (MitoQ)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267926
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Multiple Sclerosis Fatigue Drug: 20 mg MitoQ Drug: Placebo Drug: 40mg of MitoQ 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized trial
Masking: Double (Participant, Investigator)
Masking Description: The subject and investigator will be blinded.
Primary Purpose: Treatment
Official Title: MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Subject will receive Placebo

Active Comparator: 20mg of MitoQ
20mg of oral mitoquinol
Drug: 20 mg MitoQ
a third of subject will receive 20mg of oral MitoQ
Other Name: Oral Mitoquinol

Active Comparator: 40mg of MitoQ
40mg of Oral Mitoquinol
Drug: 40mg of MitoQ
a third of subjects will receive 40mg of MitoQ
Other Name: Oral Mitoquinol




Primary Outcome Measures :
  1. Modified Fatigue Inventory Scale (MFIS) [ Time Frame: 12 weeks ]
    MFIS is a self -reported fatigue survey. Scale 0 - 84


Secondary Outcome Measures :
  1. Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 weeks ]
    SDMT measures cognitive function. Scale 0-110

  2. Expanded Disability Status Scale (EDSS) [ Time Frame: 12 weeks ]
    EDSS measures neurological function. Scale 0-10

  3. Beck's Depression Inventory (BDI) [ Time Frame: 12 weeks ]
    BDI is a self-reported questionnaire measuring depression. Scale 0-21



Information from the National Library of Medicine

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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 2017 McDonald criteria
  • 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 or BDI-FS>10 (severe depression)
  • significant MS exacerbation in prior 30 days
  • previous use of MitoQ or Coenzyme Q10 (CoQ10) within thirty days of screening appointment
  • 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

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): NCT04267926


Contacts
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Contact: Allison Fryman (503) 220-8262 Allison.Fryman@va.gov
Contact: Vijayshree Yadav, MBBS (503) 220-8262 vijayshree.yadav@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Contact: Allison Fryman    503-220-8262    Allison.Fryman@va.gov   
Contact: Vijayshree Yadav, MBBS    (503) 220-8262    vijayshree.yadav@va.gov   
Principal Investigator: Vijayshree Yadav, MBBS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Vijayshree Yadav, MBBS VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04267926    
Other Study ID Numbers: NURB-022-19S
4337 ( Other Grant/Funding Number: CSR&D )
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Multiple Sclerosis
Fatigue
Mitochondrial
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
Signs and Symptoms
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs