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NCT06564974 · ClinicalTrials.gov registry record

Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT

A clinical trial of Duchenne Muscular Dystrophy, sponsored by Catalyst Pharmaceuticals.

Recruiting
Registry status
250
Enrollment target
20
Study locations

NCT06564974 is a study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Catalyst Pharmaceuticals. The registered enrollment target is 250 participants, below the 407-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06564974, a study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Catalyst Pharmaceuticals.

RECRUITING
Registry status
250 participants
Enrollment target
20
Study locations

Study Summary

The goal of this study is to collect additional information on the safety of long-term treatment with AGAMREE® and to explore long-term clinical impact of AGAMREE® on quality of life, as assessed by standardized patient-reported outcome measures (QoL questionnaires) in male patients aged 2 years and older with Duchenne muscular dystrophy (DMD).

Interventions

  • DRUG Vamorolone

Study Locations (20)

Florida

  • University of Florida Clinical and Translational Science Institue - Gainesville
  • Nicklaus Children's Hospital - Miami
  • Nemours Children's Hospital - Orlando
  • Johns Hopkins All Children's Hospital - St. Petersburg

California

  • Children's Hospital Los Angeles - Los Angeles
  • Stanford University - Palo Alto
  • University of California, Davis - Sacramento

North Carolina

  • Atrium Health Neurosciences Institute - Charlotte
  • Duke University Medical Center and Childrens Health Center - Durham

Pennsylvania

  • Penn State Milton S. Hershey Medical Center- Penn State Hershey Neuroscience Institute - Hershey
  • Children's Hospital of Philadelphia (CHOP) - Philadelphia

Arizona

  • Phoenix Children's Hospital - Phoenix

Arkansas

  • Arkansas Childrens Hospital - Little Rock

Illinois

  • Lurie Children's Hospital of Chicago - Chicago

Indiana

  • Indiana University Health - Riley Hospital for Children - Indianapolis

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2024-09-25
Est. Completion 2032-02

Sponsor

Catalyst Pharmaceuticals

10 total trials

What the Registry Record Tells You About NCT06564974

The ClinicalTrials.gov registry entry for NCT06564974 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (39% lower). The listed sponsor is Catalyst Pharmaceuticals, which has 10 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 Vamorolone is the first listed.

NCT06564974 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06564974 about?

NCT06564974 is a clinical study titled "Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT". The goal of this study is to collect additional information on the safety of long-term treatment with AGAMREE® and to explore long-term clinical impact of AGAMREE® on quality of life, as assessed by standardized patient-reported outcome measures (QoL questionnaires) in male patients aged 2 years and...

What is the current status of trial NCT06564974?

This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2024-09-25. Estimated completion is 2032-02.

What conditions does trial NCT06564974 study?

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

What interventions are being tested in trial NCT06564974?

The interventions under investigation include: Vamorolone (DRUG).

Who is sponsoring clinical trial NCT06564974?

This trial is sponsored by Catalyst Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06564974 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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