DISEASE CLASSIFICATION(S):
Amyotrophic Lateral Sclerosis(ALS)
NAME OF CLINICAL TRIAL/STUDY:
Co-Q10 Enzyme - Double Blind Study in ALS
TRIAL RESULTS:
8/2004
According to the summer 2004 issue of a newsletter published by the Eleanor and Lou Gehrig MDA/ALS Center at Columbia University, coenzyme Q10 has shown itself to be safe for ALS patients in a small, pilot trial conducted at that center.
The trial, in which 20 people (not the anticipated 35) with ALS received either coenzyme Q10 (coQ10) or a placebo (inactive substance), showed that the medication was well tolerated in general, although some participants experienced stomach upset or other gastrointestinal symptoms. The pilot trial was not designed to show effectiveness.
CoQ10 is thought to improve the activity of the mitochondria, the energy "factories" inside cells, and also to combat damage from free radicals, toxic compounds produced by cellular metabolism. It’s been shown to be beneficial in mice with genetic ALS and in people with Parkinson’s disease.
The newsletter notes that Petra Kaufmann, assistant professor of neurology at Columbia, has received a grant from the National Institutes of Health to conduct a multicenter trial of coQ10 to test its effectiveness and the proper dosage in ALS. Kaufmann emphasized in the article that it isn’t yet known whether coQ10 is effective in ALS and that people should not take it outside a clinical trial. In a plea for patience so that the drug can be properly tested, she cautioned, "If everyone is on it, there will be no way to determine whether it is helpful or not."
PURPOSE AND RATIONALE:
The purpose of this project is to test the efficacy of coenzyme Q10 (CoQ10) in Amyotrophic Lateral Sclerosis (ALS). CoQ10 is a naturally-occurring compound that is an essential cofactor in energy metabolism at the cellular level. This study will involve neuro-imaging using a novel technology of magnetic resonance imaging (similar to an MRI) to assess the efficacy of coenzyme Q10 in ALS. The study is 4 weeks in duration with weekly visits to the center. After study completion participants will be provided the opportunity to continue taking coq10 for an additional 6 months at no charge.
OPENING DATES:
Feb 1 2002
CLOSING DATES:
Feb 1 2003
TARGET NUMBER OF PARTICIPANTS:
35
RECRUITMENT STATUS:
Closed
ELIGIBILITY REQUIREMENTS:
- Diagnosis of ALS
- Tolerate MRI imaging for 60 minutes and not taking riluzole
- Travel to the study site weekly for a period of 1 month
