drugset / Trial / NCT05442775
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)
Timeline
- Start
- 2022-08-04
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
Outcome
Outcome not reported
Stopped: “The DMC recommended the trial be discontinued due to futility following a planned second interim analysis of the parent trial (CY 5031).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reldesemtiv | Small molecule | 150 mg | Oral |
| Subject | Reldesemtiv | Small molecule | 300 mg | Oral |