Multiple Sclerosis Clinical Trial
— MitoQOfficial title:
MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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 |
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