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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 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.

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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.

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

Sponsor

Capricor

9 total trials

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What the Registry Record Tells You About NCT06304064

The ClinicalTrials.gov registry entry for NCT06304064 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (98% lower). The listed sponsor is Capricor, which has 9 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.