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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 is a Phase 3 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 131 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03703882
The ClinicalTrials.gov registry entry for NCT03703882 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 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 2 interventions - of which Placebo is the first listed.
NCT03703882 reports 0 study locations.
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.
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