Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease) Clinical Trials

• Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.

• Age 18 years or older.

• Capable of providing informed consent and complying with study procedures, in the SI's opinion.

• Time since onset of weakness due to ALS ≤ 24 months at the time of the Master Protocol Screening Visit.

• Vital Capacity ≥ 50% of predicted capacity at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC) measured in person.

• Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit.

• Participants must either not take edaravone or have completed at least one cycle (typically 14 days) of edaravone prior to the Master Protocol Screening Visit.

• Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study.

• Geographically accessible to the site.