A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. A list of key criteria is listed below: Inclusion Criteria: * Onset of symptoms less than 3 years prior to study entry. * Forced Vital Capacity (FVC) at least 70% of that predicted for age and height. * Stable dose of riluzole if undergoing treatment with this agent. * For females: Not be of childbearing potential or agree to use adequate birth control during the study. Exclusion Criteria: * Unstable medical condition(s) other than ALS. * Life expectancy of less than 6 months. * Require life-sustaining interventions for the 6 months following randomization. * Have a tracheotomy or be using ventilatory assistance \[including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)\]. * Active pulmonary disease. * Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.