Trial Information

Summary: Clinical Trial of High Dose CoQ10 in ALS

Background information:

Research implicates that mitochondria, the powerhouses of the cell, are affected in Lou Gehrig’s disease. Other data suggest that “free radicals”, very reactive oxygen species, contribute to the nerve cell damage. Coenzyme Q10 (CoQ10), a natural nutrient, helps mitochondrial function and scavenges free radicals. It has prolonged survival in a mouse model of Lou Gehrig’s disease. Furthermore, it has helped patients with Parkinson’s disease, another disease caused by nerve cell loss. We therefore believe that CoQ10 is a promising treatment for Lou Gehrig’s disease. In two small studies we have given CoQ10 to patients with Lou Gehrig’s disease and found that it was well absorbed by the body and also safe and well tolerated.

Information on the Clinical Trial of High Dose CoQ10 in ALS:

The clinical trial is a double-blind, placebo-controlled, multi-center phase II clinical trial. Subjects will be randomly assigned to CoQ10 (at two different dose levels) or placebo. The trial is 9 months in duration with a total of 7 visits. The first visit is a screening visit, roughly 2 weeks later there is a baseline visit, and then subsequent visits at months 1, 3, 5, 7, 9 and a phone call at month 10. Each visit takes about 1-2 hours. Participants will be asked to answer questions and take a breathing test. Muscle testing is not required.

This trial is funded by the NIH and will evaluate the safety and efficacy of CoQ10 in ALS. Given the promising preclinical data and good results of CoQ10 treatment in other neurological diseases, it is very important to study if CoQ10 can help ALS patients. A controlled clinical trial is the best way to answer this question. Your participation will benefit ALS research and future ALS patients.

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Trial listings updated: June 1, 2008 at 5:45:03 AM