MitoQ for Fatigue in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— MitoQ  

Official title:

MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267926
• Other study ID #: NURB-022-19S
• Secondary ID: 4337
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Allison Fryman
• Phone: (503) 220-8262
• Email: fryman[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 20 mg MitoQ
a third of subject will receive 20mg of oral MitoQ
• Placebo
Subject will receive Placebo
• 40mg of MitoQ
a third of subjects will receive 40mg of MitoQ

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Fatigue Inventory Scale (MFIS)	MFIS is a self -reported fatigue survey. Scale 0 - 84	12 weeks
Secondary	Symbol Digit Modalities Test (SDMT)	SDMT measures cognitive function. Scale 0-110	12 weeks
Secondary	Expanded Disability Status Scale (EDSS)	EDSS measures neurological function. Scale 0-10	12 weeks
Secondary	Beck's Depression Inventory (BDI)	BDI is a self-reported questionnaire measuring depression. Scale 0-21	12 weeks