Clinical trial

MitoQ for Fatigue in Multiple Sclerosis: a Placebo Controlled Trial

Name

STUDY00015779

Description

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.

Trial arms

Trial start

2018-09-15

Estimated PCD

2019-01-10

Trial end

2019-01-10

Status

Terminated

Phase

Early phase I

Treatment

Mitoquinone

This arm of the intervention the study subject will be administered 40mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

Arms:

40mg oral MitoQ

Other names:

mitoquinol

Mitoquinone

This arm of the intervention the study subject will be administered 20mg of the study drug MitoQ orally in capsule form every morning for 12 weeks.

Arms:

20mg oral MitoQ

Other names:

mitoquinol

Placebo

This arm of the intervention the study subject will be administered placebo capsules to orally take every morning for 12 weeks.

Arms:

Placebo

Size

Primary endpoint

Fatigue measured by Modified Fatigue Impact Scale (MFIS) Score at 12 weeks post study drug initiation

Baseline to 12 weeks post drug initiation.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

Updated at

2023-04-05

1 organization

1 product

1 drug

2 indications

Organization

Oregon Health and Science University

Product

Indication

Indication

Drug