drugset / Trial / NCT01709149
Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tirasemtiv | Other / unclassified | 125 mg | — |
| Subject | tirasemtiv | Other / unclassified | 250 mg | — |
| Background | Riluzole | Small molecule | — | — |