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NCT05442775 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
A Phase 3 study, sponsored by Cytokinetics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT05442775: Clinical Trial Phase 3 study, sponsored by Cytokinetics.
NCT05442775 is a Phase 3 study that was terminated before completion, run by Cytokinetics. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05442775, a Phase 3 study, was terminated before completion, sponsored by Cytokinetics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study 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)
Primary Outcome
Incidence of treatment-emergent adverse events
Interventions
- DRUG Reldesemtiv
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-08-04 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 3 |
Why NCT05442775 stopped before completion
NCT05442775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Reldesemtiv is the first listed.
NCT05442775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05442775 about?
NCT05442775 is a clinical study titled "A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)". 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)
What is the current status of trial NCT05442775?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2022-08-04. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT05442775?
The interventions under investigation include: Reldesemtiv (DRUG).
Who is sponsoring clinical trial NCT05442775?
This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05442775's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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