HF Clinical Trials

COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS)
Status: Stopped for Futility

COURAGE-ALS was a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv in patients with ALS. The primary efficacy endpoint was changed from baseline to 24 weeks in ALSFRS-R. Secondary endpoints included combined assessment of ALSFRS-R total score, time to onset of respiratory insufficiency and survival time up to week 24 using a joint rank test; change from baseline to 24 weeks for vital capacity; ALSAQ-40; and bilateral handgrip strength. In March 2023, COURAGE-ALS met criteria for futility at the second planned interim analysis.

COURAGE-ALS OLE (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS Open-Label Extension)
Status: Stopped for Futility

COURAGE-ALS OLE was an open-label extension clinical study designed to assess the long-term safety and tolerability of reldesemtiv in people with amyotrophic lateral sclerosis (ALS). Patients were eligible for COURAGE-ALS OLE after completing their participation in COURAGE-ALS, the Phase 3 clinical trial of reldesemtiv. In March 2023, COURAGE-ALS met criteria for futility at the second planned interim analysis.

FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints in ALS)
Status: Complete

FORTITUDE-ALS was a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in 458 patients with ALS. The primary endpoint was the change from baseline in the percent predicted SVC at 12 weeks. Secondary endpoints included change from baseline in the ALSFRS-R total score and the slope of the change from baseline in the mega-score of muscle strength measured by handheld dynamometry and handgrip dynamometry in patients on reldesemtiv; incidence and severity of treatment-emergent adverse events (TEAEs); and plasma concentrations of reldesemtiv at the sampled time points during the clinical trial.