Overview

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