Clinical trial NCT03166800: MitoQ for Fatigue in Multiple Sclerosis
Official title: MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Fatigue
Keywords: mitoquinone
Fatigue
Multiple Sclerosis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: MitoQ Limited
name: National Multiple Sclerosis Society
First posted: 2017-05-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation
timeFrame: Baseline to 12 weeks post drug initiation.
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Vijayshree Yadav, MD
role: PRINCIPAL_INVESTIGATOR
References: