drugset / Trial / NCT01709149

Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

NCT01709149 ↗

Phase 2 Completed 711 enrolled Cytokinetics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

Timeline

Start
2012-10
Primary completion
2014-03
Completion
2014-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Tirasemtiv; p = 0.1140; Least squares mean difference -0.58 (95% CI -1.30 to 0.14) NCT01709149 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject tirasemtiv Other / unclassified 125 mg —
Subject tirasemtiv Other / unclassified 250 mg —
Background Riluzole Small molecule — —