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A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031) — COURAGE OLE  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

Clinical Trial 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)

Clinical Trial Description

CY 5032 is an open-label extension (OLE) study of the selective fast skeletal muscle troponin activator, reldesemtiv, in patients with ALS who finished dosing (through Week 48) in CY 5031 (COURAGE-ALS). Approximately 400 patients from the sites that participated in CY 5031 are expected to be enrolled in the open-label extension, CY 5032. Following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (TDD) for a period of 48 weeks. At the end of 48 weeks, patients may transition to a reldesemtiv Managed Access Program (MAP) the treating physician agrees to participate in the program. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05442775
Study type Interventional
Source Cytokinetics
Contact
Status Terminated
Phase Phase 3
Start date July 25, 2022
Completion date June 7, 2023
View Details
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