Major Inclusion Criteria:
- Male or female subjects age 18 - 80 years, inclusive; - Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory-supported]; - ALS onset of ≤18 months from first clinical signs of weakness prior to screening; - Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug; - If currently using edaravone, subject should have completed at least one cycle of edaravone prior to Screening visit; - Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted;; - Able to swallow study medication capsules; - No known allergies to the study drug or its excipients; - Received pneumococcal vaccine within 6 years prior to starting clinical trial.
Major Exclusion Criteria:
- ALSFRS-R score of ≤1 on more than one item in the assessment's individual components; - Currently use or treated with Nuedexta® ≤3 months prior to signing consent; - Currently use or treated with Methylcobalamin Vitamin B12 ≤3 months prior to signing consent - Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator; - Use of tracheostomy or >22/24-hour ventilatory support.

• MediciNova

NCT04057898 (First Published: 8/6/2019)