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NCT06304064 · ClinicalTrials.gov registry record · Phase 2

Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)

A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Capricor.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target
2
Study locations

NCT06304064: Completed Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Capricor.

NCT06304064 is a Phase 2 study of Duchenne Muscular Dystrophy that has completed, run by Capricor. The registered enrollment target is 8 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06304064, a Phase 2 study of Duchenne Muscular Dystrophy, has completed, sponsored by Capricor.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target
2
Study locations

Study Summary

This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up. The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months.

Primary Outcome

Acute respiratory decompensation is defined as an unexplained rapid deterioration of the participant's condition with increasing shortness of breath requiring oxygen supplementation. Acute respiratory decompensation within 2 hours following investigational product (IP) administration will be reported.

Conditions Studied

Duchenne Muscular Dystrophy

Interventions

  • BIOLOGICAL Allogeneic Cardiosphere-Derived Cells (CAP-1002)

Study Locations (2)

Florida

  • University of Florida - Gainesville

Ohio

  • Cincinnati Children's Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-06-21
Est. Completion 2019-03-06
Phase Phase 2
Capricor

9 total trials

What the finished NCT06304064 record still lists

NCT06304064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic Cardiosphere-Derived Cells (CAP-1002) is the first listed.

NCT06304064 reports a single indexed study location in Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT06304064 about?

NCT06304064 is a clinical study titled "Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)". This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up. The trial will assess the safety and efficacy of two intravenous administ...

What is the current status of trial NCT06304064?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-06-21. Estimated completion is 2019-03-06.

What conditions does trial NCT06304064 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT06304064?

The interventions under investigation include: Allogeneic Cardiosphere-Derived Cells (CAP-1002) (BIOLOGICAL).

Who is sponsoring clinical trial NCT06304064?

This trial is sponsored by Capricor, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06304064 being conducted?

This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Duchenne Muscular Dystrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06304064's enrollment target sits among peer trials

8 45th of 48 higher than 3 of 48 other Duchenne Muscular Dystrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy 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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Related registry views

Source: ClinicalTrials.gov NCT06304064, the US trial registry maintained by the National Library of Medicine. NCT06304064 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.