RecruitingNCT06564974

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

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


Sponsor

Catalyst Pharmaceuticals, Inc.

Enrollment

250 participants

Start Date

Sep 25, 2024

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vamorolone for people with duchenne muscular dystrophy. The study is currently recruiting participants at 33 locations. People eligible for this study include men aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVamorolone

Study treatment is AGAMREE®, which is commercially available as an oral suspension.


Locations(33)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

Loma Linda University Pediatric Subspecialty Clinics

Loma Linda, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Valley Children's Hospital

Madera, California, United States

Stanford University

Palo Alto, California, United States

University of California, Davis

Sacramento, California, United States

Children's National Health System

Washington D.C., District of Columbia, United States

University of Florida Clinical and Translational Science Institue

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Indiana University Health - Riley Hospital for Children

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Massachusetts Memorial Medical Center

North Worcester, Massachusetts, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Masonic Children's Hospital - Discovery Clinic

Minneapolis, Minnesota, United States

The Children's Hospital at Montefiore

The Bronx, New York, United States

Atrium Health Neurosciences Institute

Charlotte, North Carolina, United States

Duke University Medical Center and Childrens Health Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Penn State Milton S. Hershey Medical Center- Penn State Hershey Neuroscience Institute

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Neurology Rare Disease Center - Neurology & Neuromuscular Care Center

Denton, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Virginia Health System (UVAHS) - Pediatric Neuromuscular Center

Charlottesville, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Wisconsin

Milwaukee, Wisconsin, United States

San Jorge Children's Hospital

San Juan, Puerto Rico, Puerto Rico

FDI Clinical Research

San Juan, Puerto Rico, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT06564974


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