Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Catabasis Pharmaceuticals.
NCT03917719 is a Phase 3 study that was terminated before completion, run by Catabasis Pharmaceuticals. The registered enrollment target is 130 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT03917719 stopped before completion
NCT03917719 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Edasalonexent is the first listed.
NCT03917719 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03917719's enrollment target sits among peer trials
130 1594th of 2000 higher than 404 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492036 · 130 participants
Long-Term Follow-Up of Recipient of Gene Transfer Research
- NCT01631617 · 130 participants · Phase 2
Effects of Treatments on Atopic Dermatitis
- NCT02368041 · 130 participants
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- NCT02604277 · 130 participants · NA
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI