ALS (Amyotrophic Lateral Sclerosis) Trials

Prinicipal Investigator:
Carlayne Jackson, MD

Study Coordinator:
Randee Kent Baron, LVN

HEALEY ALS Platform Trial:

Eligibility
1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria (Appendix I).
2. Age 18 years or older.
3. Capable of providing informed consent and complying with study procedures, in the SI’s opinion.
4. Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit.
5. SVC ≥ 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit.
6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study.
7. Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study.
8. 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 pills for the duration of the study.
9. Geographically accessible to the site.

Study Duration
Treatment duration of placebo-controlled regimens is a maximum of 24-weeks for each regimen. An optional open label extension (OLE) may be offered and will be described in the respective RSAs.

CReATe: Clinical Research in ALS and Related Disorders for Therapeutic Development Consortium:

Eligibility
1. Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy)
2. Receiving care at a clinical center that uses Epic as its EHR.
3. Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).

Observational Study
Return visits (frequency dictated by clinical needs)