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NCT03917719 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
A Phase 3 study, sponsored by Catabasis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
NCT03917719 is a Phase 3 study that was terminated before completion, run by Catabasis Pharmaceuticals. The registered enrollment target is 130 participants.
The verdict
NCT03917719, a Phase 3 study, was terminated before completion, sponsored by Catabasis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
Study Summary
The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.
Interventions
- DRUG Edasalonexent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2020-10-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03917719
The ClinicalTrials.gov registry entry for NCT03917719 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catabasis Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Edasalonexent is the first listed.
NCT03917719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03917719 about?
NCT03917719 is a clinical study titled "An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy". The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 ...
What is the current status of trial NCT03917719?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2019-03-14. Estimated completion is 2020-10-26.
What interventions are being tested in trial NCT03917719?
The interventions under investigation include: Edasalonexent (DRUG).
Who is sponsoring clinical trial NCT03917719?
This trial is sponsored by Catabasis Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
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