CuATSM Compared With Placebo for Treatment of ALS/MND

Inclusion Criteria: * signed informed consent * familial or sporadic ALS/MNS by Awaji-shima Consensus Recommendations * not taking riluzole or on stable dose of riluzole for 4 weeks prior to screening visit * no prior exposure to agents other than riluzole for treatment of ALS * adequate bone marrow reserve, renal and liver function * women of childbearing potential must have a negative pregnancy test and be non-lactating * women and men with partners of childbearing potential must take effective contraception while on treatment Exclusion Criteria: * presence of a gastrointestinal disorder (eg, malabsorption) that might jeopardize intestinal absorption of study drug * inability to perform seated SVC * known immune compromising illness or treatment * drug abuse or alcoholism * clinically significant or active cardiovascular disease * acute or chronic infection * diagnosis of malignancy within 2 years prior to screening * dementia that may affect patient understanding and/or compliance with study requirements and procedures * current use of strong inducers or inhibitors of CYPs 2C19 and 2D6 * current us of medications (other than riluzole) that are metabolized predominantly by CYP 1A2