Clinical Trial of High Dose CoQ10 in ALS

AAAA1536

The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study.

2005-04-01

2008-03-01

2008-03-01

Completed

Early phase I

185

Inclusion Criteria: * Clinical diagnosis of definite, probable, or laboratory-supported probable ALS * Negative pregnancy test for women of childbearing age and adequate birth control measures * Subjects must be able and willing to give informed consent and must be capable of complying with the trial procedures * Forced Vital Capacity (FVC) \>/= 60% of predicted * Age 21 to 85 years, inclusive * Disease duration of less than 5 years * Subjects may take riluzole (without change in dose for more than 30 days before enrollment) * Patients who have taken CoQ10 in the past will be eligible if they stop at least 30 days before enrollment * Patients who have taken vitamin E in the past will be eligible if they stop at least 14 days before enrollment Exclusion Criteria: * Dependency on mechanical ventilation (non-invasive ventilation \> 23 hours) * Severe and unstable concomitant medical or psychiatric illness * Insufficiently controlled diabetes mellitus * Concomitant warfarin therapy * Women who are breast feeding or have a high likelihood of pregnancy * Significant hepatic dysfunction * Forced Vital Capacity (FVC) less than 60% * Exposure to CoQ10 within 30 days of enrollment * Exposure to other experimental medications within 30 days of enrollment * Exposure to vitamin E within 14 days of enrollment * Sensitivity to color additive FD\&C Yellow No. 5 * Sensitivity to aspirin

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 185, 'type': 'ACTUAL'}}

2024-05-07