Research Update Modafinil as a treatment for fatigue Fatigue is common in ALS and is often reported to be one of the most disabling secondary symptoms of the diagnosis. The New York State Psychiatric Institute and the Eleanor and Lou Gehrig MDA/ALS Research Center are now recruiting for a clinical trial of Modafinil (Provigil) for the treatment of fatigue in ALS. Modafinil is an FDA approved medication to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. It is now being studied for its effects on fatigue in other conditions including ALS. At study completion, the investigators hope to have a better understanding of tolerability and side effects of Modafinil as well as get a preliminary sense of efficacy. Our research, and future patients with ALS, will benefit from your participation. For more information on the trial, please contact: Judith Rabkin, Ph.D: jgr1@columbia.edu or 212-543-5762 Martin McElhiney, Ph.D: mcelhin@pi.cpmc.columbia.edu or 212-543-5331 Background information regarding CoQ10 and the upcoming trial. Research suggests 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. The clinical trial is a double-blind, randomized, placebo-controlled, multicenter phase II clinical trial. This means that there will be two groups to which subjects will be randomly assigned. Neither the treating physician nor the patient will know which treatment group they have been assigned to since both doses look and taste the same. We will be testing the safety and efficacy of a high dose of CoQ10 against a placebo (inactive substance). The trial is 9 months in duration with a total of 7 office visits. The first visit is a screening visit and then 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 2 hours. Muscle testing is not required for this trial but we will measure breathing. BiPap or Non-invasive Ventilation in ALS In this clinical trial, which is designed to determine oxygen saturation during sleep, we are currently enrolling patients with ALS who use non-invasive ventilation (BiPAP). Paticipation in the trial is free and involves delivery of sleep study equipment to the patient s home, also at no cost. The equipment is non-invasive and comfortable. If you or someone you know has been using BiPap for at least 4 hours a night for a month, and would like further information about how to participate in the study, please call Jackie Montes at 212-305-3632, or email her at www.columbiaals.org.