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NCT02439216 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study in Boys With Duchenne Muscular Dystrophy
A Phase 1 study, sponsored by Catabasis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02439216 is a Phase 1 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 31 participants.
The verdict
NCT02439216, a Phase 1 study, has completed, sponsored by Catabasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to \<8 years of age will be enrolled. Edasalonexent is an orally administered small molecule targeted to inhibit activated NF-κB, a molecule that is activated from infancy in DMD and which is central to causing muscle damage and preventing muscle regeneration. Data on magnetic resonance imaging of the lower and upper leg muscles, physical function (including timed function tests) and muscle strength will be studied.
Interventions
- DRUG Placebo
- DRUG Edasalonexent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02439216
The ClinicalTrials.gov registry entry for NCT02439216 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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.
NCT02439216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02439216 about?
NCT02439216 is a clinical study titled "Phase 1/2 Study in Boys With Duchenne Muscular Dystrophy". The MoveDMD study is a 3-part, Phase 1/2, multi-site study to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of edasalonexent (also known as CAT-1004) in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from ≥4 to \<8 years of age will b...
What is the current status of trial NCT02439216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2016-04. Estimated completion is 2019-08.
What interventions are being tested in trial NCT02439216?
The interventions under investigation include: Placebo (DRUG), Edasalonexent (DRUG).
Who is sponsoring clinical trial NCT02439216?
This trial is sponsored by Catabasis Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
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