MitoQ for Fatigue in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 April 2023
• Main ID: NCT03166800
• Date of registration: 23/05/2017
• Prospective Registration: Yes
• Primary sponsor: Oregon Health and Science University
• Public title: MitoQ for Fatigue in Multiple Sclerosis MS
• Scientific title: MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial
• Date of first enrolment: September 15, 2018
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03166800
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Vijayshree Yadav, MD
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fatigue

Multiple Sclerosis

Intervention(s)

Drug: Mitoquinone

Drug: Placebo

Primary Outcome(s)

Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation [Time Frame: Baseline to 12 weeks post drug initiation.]

Secondary ID(s)

STUDY00015779

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MitoQ Limited

National Multiple Sclerosis Society