MitoQ for Fatigue in Multiple Sclerosis (MS)

NCT04267926 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: NURB-022-19S4337
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Fatigue

Keywords

Multiple Sclerosis; Fatigue; Mitochondrial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symbol Digit Modalities Test (SDMT)

  Week 1, Week 7, Week 13

• Expanded Disability Status Scale (EDSS)

  12 weeks

• Beck's Depression Inventory (BDI)

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

20mg of MitoQ

ACTIVE COMPARATOR

20mg of oral mitoquinol

Drug: 20 mg MitoQ

40mg of MitoQ

ACTIVE COMPARATOR

40mg of Oral Mitoquinol

Drug: 40mg of MitoQ

Interventions

20 mg MitoQ DRUG

a third of subject will receive 20mg of oral MitoQ

Also known as: Oral Mitoquinol

20mg of MitoQ

Placebo DRUG

Subject will receive Placebo

Placebo

40mg of MitoQ DRUG

a third of subjects will receive 40mg of MitoQ

Also known as: Oral Mitoquinol

40mg of MitoQ

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

mitoquinone; mitoquinol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

While the original sample size was 60 we were able to enroll only 45 subjects out of which 43 completed all visits. The study was affected due to COVID-19 and OHSU/VA contract delays.

Results Point of Contact

• Title: Vijayshree Yadav MBBS, MCR
• Organization: Department of Veterans Affairs MS Center of Excellence-West and Portland, Oregon Health & Science University

yadavv@ohsu.edu

503-494-3813

Study Officials

• Vijayshree Yadav, MBBS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject and investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized trial

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: April 1, 2020
• Primary Completion: October 15, 2024
• Study Completion: March 31, 2026
• Last Updated: April 24, 2026
• Results First Posted: October 29, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)