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NCT03703882 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
A Phase 3 study, sponsored by Catabasis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT03703882: Completed Phase 3 study, sponsored by Catabasis Pharmaceuticals.
NCT03703882 is a Phase 3 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 131 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
NCT03703882, a Phase 3 study, has completed, sponsored by Catabasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study Summary
The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the 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.
Primary Outcome
To assess change from baseline in North Star Ambulatory Assessment(NSAA) Total Score at Wk52. NSAA is clinician-reported outcome instrument designed to measure ambulatory function in males with Duchenne muscular dystrophy(DMD). Patients asked to perform 17 different functional activities,including 10MWT,rising from sit to stand,standing on one leg,climbing \& descending a step,stand from supine, lifting the head, standing on heels, \& jumping. Each function activity will be scored as0=(unable to
Interventions
- DRUG Placebo
- DRUG Edasalonexent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2020-09-22 |
| Phase | Phase 3 |
What the finished NCT03703882 record still lists
NCT03703882 is an interventional study that assigns participants to a tested intervention. The registered 131 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 2 interventions - of which Placebo is the first listed.
NCT03703882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03703882 about?
NCT03703882 is a clinical study titled "Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy". The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled. Edasalonexent is an orally administered small molecule...
What is the current status of trial NCT03703882?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2018-10-02. Estimated completion is 2020-09-22.
What interventions are being tested in trial NCT03703882?
The interventions under investigation include: Placebo (DRUG), Edasalonexent (DRUG).
Who is sponsoring clinical trial NCT03703882?
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 NCT03703882's enrollment target sits among peer trials
131 1593rd of 2000 higher than 407 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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