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

MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Fatigue
• Intervention / Treatment: Drug: Placebo; Drug: 20 mg MitoQ; Drug: 40mg of MitoQ

Detailed Description

Recruitment of subjects on hold due to COVID-19 pandemic

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • VA Portland Health Care System, Portland, OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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 Names: 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 Names: Oral Mitoquinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Fatigue Inventory Scale (MFIS)	MFIS is a self - reported fatigue survey. Scale 0 - 84. Higher scores indicate a greater impact of fatigue.	Week 1, Week 7, Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded Disability Status Scale (EDSS)	EDSS measures neurological function. Scale 0-10	12 weeks
Beck's Depression Inventory (BDI)	BDI is a self-reported questionnaire measuring depression. Scale 0-21	12 weeks
Symbol Digit Modalities Test (SDMT)	SDMT measures cognitive function. Scale 0-110. Higher scores reflect a better outcome.	Week 1, Week 7, Week 13

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Vijayshree Yadav, MBBS, VA Portland Health Care System, Portland, OR

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Fatigue; Mitochondrial
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Sclerosis; Fatigue; Physiological Effects of Drugs; Micronutrients; mitoquinone; mitoquinol
• Other Study ID Numbers: NURB-022-19S; 4337 (Other Grant/Funding Number: CSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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