Clinical Trial of High Dose CoQ10 in ALS

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Antioxidants; Coenzyme Q10; Ubiquinone

Criteria

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