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

NCT05442775 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-08-13

Study results available
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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)

Conditions

Interventions

DRUG

Reldesemtiv

Oral tablet

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Cytokinetics MD · Scientific Leadership at Cytokinetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2023-06-07
Completion
2023-06-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442775 on ClinicalTrials.gov