The HEALEY ALS Platform Trial
Condition: Amyotrophic lateral sclerosis
Key Inclusion Criteria:
- Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS
- At least 18 years old
- Time since onset of weakness due to ALS ≤36 months at the time of the screening visit
Key Exclusion Criteria:
- Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant
- Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent
- Active cancer or history of cancer (with certain exceptions)
The HEALEY ALS Platform Trial (IRB no. 00000445)
The purpose of the HEALEY ALS Platform Trial is to evaluate the safety and effectiveness of multiple treatments for amyotrophic lateral sclerosis (ALS). A regimen is a specific course of treatment, each with a different study drug. Multiple regimens may be active at the same time within this platform trial.
Participants will be randomly assigned to a regimen (one treatment). Within a regimen, participants will have a 3 in 4 chance of being assigned to the active drug group and a 1 in 4 chance of being assigned to the placebo (inactive substance) group. Researchers aim to determine whether these treatments have an effect on ALS and can be safely used without causing excessive side effects.