Overview

MitoQ for Fatigue in Multiple Sclerosis

Status:
Completed
Trial end date:
2019-11-05
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oregon Health and Science University
Collaborator:
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.