MitoQ for Fatigue in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MS  

Official title:

MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03166800
• Other study ID #: STUDY00015779
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 15, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: March 2023
• Source: Oregon Health and Science University
• Contact: n/a
• 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 study drug initiation will assess if MitoQ has a significant change in fatigue.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• MS (any clinical subtype) as diagnosed by the 2010 McDonald criteria40;
• Expanded Disability Status Scale (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 (severe depression);
• Significant MS exacerbation in prior 30 days;
• Previous use of MitoQ or CoQ-10 within 30 days of screening appointment;
• Use of non-research-pharmacy-administered MitoQ or CoQ-10 during the duration of the study;
• Other significant health problem (e.g. active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus) that might increase risk of patient experiencing adverse events),
• Pregnancy or intending to become pregnant or breastfeeding;
• Unable to complete the self-report forms;
• Unable to give informed consent;
• Prisoners will be excluded.
• 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:
• 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.
• 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.
• Placebo
This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	MitoQ Limited, National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation	This primary outcome measure will be the difference from baseline in fatigue scores as measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation.	Baseline to 12 weeks post drug initiation.