NCT05442775

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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) if the treating physician agrees to participate in the program.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Reldesemtiv	Oral tablet

Timeline

• Start date: 2022-08-04
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2022-07-05
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

41 sites across 9 countries: United States, Australia, Belgium, Canada, Ireland, Italy, Netherlands, Spain, Sweden

Regulatory

• FDA-regulated drug study