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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: Completed Phase 1 study, sponsored by Catabasis Pharmaceuticals.
NCT02439216 is a Phase 1 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The LLC5-T2 calculated from the unweighted average of the T2 relaxation times of all 5 lower leg muscles for each patient at each evaluation (the medial gastrocnemius, peroneals, soleus, tibialis anterior, and tibialis posterior muscles). Increases in LLC5-T2 relaxation time indicate muscle damage, inflammation, edema, and fat infiltration and are highly correlated with muscle fat
Interventions
- DRUG Placebo
- DRUG Edasalonexent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
What the finished NCT02439216 record still lists
NCT02439216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02439216 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02439216's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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