Overview
MitoQ for Fatigue in Multiple Sclerosis
Status:
Completed
Completed
Trial end date:
2019-11-05
2019-11-05
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Oregon Health and Science UniversityCollaborator:
MitoQ Ltd
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.