NCT04944784

A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

Detailed description

COURAGE-ALS is a Phase 3, double-blind, randomized, placebo-controlled trial of reldesemtiv in patients aged 18 to 80 with ALS. The screening and qualification period for the trial will be no more than 21 days in duration. Approximately 555 eligible ALS patients will be randomized (2:1) to receive the following dose of reldesemtiv or placebo (stratified by riluzole use/non-use and edaravone use/non-use) for the first 24 weeks (double-blind, placebo-controlled period): * 300 mg reldesemtiv twice a day for a 600 mg total daily dose (TDD) * Placebo twice daily At the end of the 24-week double-blind, placebo-controlled period, patients will transition to the active drug period, where all patients will receive the following dose of reldesemtiv for the next 24 weeks: * 300 mg reldesemtiv twice a day for a 600 mg TDD for patients who were not down titrated during the 24 weeks of blinded dosing * 150 mg reldesemtiv twice a day for a 300 mg TDD for patients who were down titrated during the 24 weeks of blinded dosing

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Reldesemtiv	Reldesemtiv Oral Tablet
DRUG	Placebo	Placebo Oral Tablet

Timeline

• Start date: 2021-08-16
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2021-06-30
• Last updated: 2024-12-05
• Results posted: 2024-12-05

Locations

84 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study