Neurology Trial: 16 week study designed to assess the effect of the drug versus placebo on respiratory function with patients with ALS

INCLUSION:

• Male/Female 18-80 years of age
• Sporadic or familial ALS <24 months prior to screening
• SVC > 65% of predicted for age/height/sex

EXCLUSION:

• At time of screening any use of non-invasive ventilation
• Neurological impairment due to a condition other than ALS
• Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with patients ability to comply with study procedures