Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

Exclusion Criteria

• •Diagnosis of Primary Lateral Sclerosis;
• •Diagnosis of Frontotemporal Dementia;
• •Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease, Alzheimer disease);
• •Diagnosis of polyneuropathy;
• •Other causes of neuromuscular weakness;
• •Have a significant pulmonary disorder not attributed to ALS and/or require treatment interfering with the evaluation of ALS on respiratory function;
• •Use of intravenous (IV) edaravone within 6 months of the screening visit;
• •Depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at Screening;
• •Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation;
• •Subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for HIV, hepatitis B or C;