NCT03166800

MitoQ for Fatigue in Multiple Sclerosis

MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis
• Fatigue

Interventions

Type	Name	Description
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.
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.
DRUG	Placebo	This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

Timeline

• Start date: 2018-09-15
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2017-05-25
• Last updated: 2023-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study