A Phase 3, Multi-Center, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with ALS
The purpose of this trial is to evaluate the effect of reldesemtiv (study drug) v. placebo on ALSFRS-R, FVC, quality of life scales, muscle and handgrip strength, ALS progression, safety, and tolerability. After an approximate 2 week screening period, eligible participants would be randomized 2:1 to receive either 300mg reldesemtiv twice daily by mouth or placebo twice daily by mouth (66% chance of being randomized to reldesemtiv, and 33% chance of being randomized to placebo) for the first 24 weeks.
At the end of the first 24 weeks, participants will transition to the active drug period, where all participants will receive the following dosing regimen for another 24 weeks: 1) 300mg reldesemtiv twice daily for participants, or 2) 150mg reldesemtiv twice daily for participants whose doses were decreased for any reason during the first 24 weeks of dosing.
There will be up to 8 clinic visits and 9 remote assessments (phone and/or video call), including screening, the 48-week treatment period, and a follow-up visit.
Principal Investigator: Shafeeq Ladha, MD