Status:
COMPLETED
Clinical Trial of High Dose CoQ10 in ALS
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Amyotrophic Lateral Sclerosis
Lou Gehrig's Disease
Eligibility:
All Genders
21-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a progressive and devastating neurodegenerative disorder. Available treatment for ALS remains scarce. Oxidative stress and mitochondrial dysfunction have been im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00243932
Start Date
April 1 2005
End Date
March 1 2008
Last Update
May 7 2024
Active Locations (19)
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1
University of Arkansas for Medical Sciences, Department of Neurology
Little Rock, Arkansas, United States, 72201
2
California Pacific Medical Center
San Francisco, California, United States, 94101
3
University of California at San Francisco
San Francisco, California, United States, 94101
4
University of Colorado Health Sciences, Dept of Neurology
Denver, Colorado, United States, 80221