Phase II Safety and Tolerability study of High Fat/High Calorie versus High Calorie versus Optimal Nutrition in Subjects with Amyotrophic Lateral Sclerosis
The purpose of this study is to find out whether a high fat or high calorie diet is safe and can be tolerated by people with amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disorder that usually leads to death in 2 to 5 years. Rapid weight loss is a hallmark of the disease, due to inadequate caloric intake and, in 80% of patients, a hypermetabolic state. Approximately 60 ALS subjects, at different treatment centers, already receiving nutrition from a tube in their st
Who may be Eligible
Male and females over the age of 18 with feeding tubes and a diagnosis of ALS.