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

ClinicalTrials.gov ID: NCT06564974

Public ClinicalTrials.gov record NCT06564974. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 12:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy [SUpplemental Patient dMd assessMents Investigating ouTcomes (SUMMIT)]

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06564974
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Catalyst Pharmaceuticals, Inc.; Industry
Enrollment: 250 participants

Conditions and interventions

Conditions

Duchenne Muscular Dystrophy

Interventions

Vamorolone Drug

Drug

Eligibility (public fields only)

Age range: 2 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 24, 2024
Primary completion: Jan 31, 2032
Completion: Jan 31, 2032
Last update posted: Jul 19, 2026

2024 – 2032

United States locations

U.S. sites: 31
U.S. states: 19
U.S. cities: 30

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoenix	Arizona	85016	Recruiting
Arkansas Childrens Hospital	Little Rock	Arkansas	72202	Recruiting
Loma Linda University Pediatric Subspecialty Clinics	Loma Linda	California	92354	Not yet recruiting
Children's Hospital Los Angeles	Los Angeles	California	90027	Not yet recruiting
Valley Children's Hospital	Madera	California	93636	Not yet recruiting
Stanford University	Palo Alto	California	94305	Not yet recruiting
University of California, Davis	Sacramento	California	95817	Not yet recruiting
Children's National Health System	Washington D.C.	District of Columbia	20010	Not yet recruiting
University of Florida Clinical and Translational Science Institue	Gainesville	Florida	32610	Not yet recruiting
University of Miami	Miami	Florida	33136	Not yet recruiting
Nicklaus Children's Hospital	Miami	Florida	33155	Recruiting
Nemours Children's Hospital	Orlando	Florida	32827	Recruiting
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	33701	Not yet recruiting
Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Indiana University Health - Riley Hospital for Children	Indianapolis	Indiana	46202	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	66205	Recruiting
University of Massachusetts Memorial Medical Center	North Worcester	Massachusetts	01655	Recruiting
Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	Recruiting
Masonic Children's Hospital - Discovery Clinic	Minneapolis	Minnesota	55455	Not yet recruiting
The Children's Hospital at Montefiore	The Bronx	New York	10467-2403	Not yet recruiting
Atrium Health Neurosciences Institute	Charlotte	North Carolina	28207	Recruiting
Duke University Medical Center and Childrens Health Center	Durham	North Carolina	27710	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Penn State Milton S. Hershey Medical Center- Penn State Hershey Neuroscience Institute	Hershey	Pennsylvania	17033	Recruiting
Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	19104	Recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	75235	Recruiting
Neurology Rare Disease Center - Neurology & Neuromuscular Care Center	Denton	Texas	76208	Recruiting
The University of Texas Health Science Center at San Antonio	San Antonio	Texas	78229	Recruiting
University of Virginia Health System (UVAHS) - Pediatric Neuromuscular Center	Charlottesville	Virginia	22903	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting
Children's Wisconsin	Milwaukee	Wisconsin	53226	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06564974, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 19, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06564974 live on ClinicalTrials.gov.

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