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NCT03406780 · ClinicalTrials.gov registry record · Phase 2
A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy
A Phase 2 study, sponsored by Capricor.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT03406780: Completed Phase 2 study, sponsored by Capricor.
NCT03406780 is a Phase 2 study that has completed, run by Capricor. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03406780, a Phase 2 study, has completed, sponsored by Capricor.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne Muscular Dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.
Primary Outcome
Change from baseline in functional capacity as assessed by the mid-level (elbow) dimension of PUL version 1.2 at Month 12 expressed as percentile ranked change. PUL 1.2 scale assesses motor performance in the upper limb. PUL 1.2 included 22 items. One entry item to define the starting functional level, and 21 items subdivided into: Shoulder Level (score 0 to 16); Elbow Level (score 0 to 34); Distal Level Dimension (score 0 to 24). The total score range was from 0 to 74. For all items, the highe
Interventions
- DRUG Placebo
- BIOLOGICAL CAP-1002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-04-04 |
| Est. Completion | 2020-03-10 |
| Phase | Phase 2 |
What the finished NCT03406780 record still lists
NCT03406780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03406780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03406780 about?
NCT03406780 is a clinical study titled "A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy". HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne Muscular Dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-10...
What is the current status of trial NCT03406780?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-04-04. Estimated completion is 2020-03-10.
What interventions are being tested in trial NCT03406780?
The interventions under investigation include: Placebo (DRUG), CAP-1002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03406780?
This trial is sponsored by Capricor, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03406780's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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