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ENROLLING BY INVITATION
NCT06066580
PHASE2

Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

Sponsor: Edgewise Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

Official title: An Open-Label Extension Study to Assess the Long-term Effect of EDG-5506 on Safety, Biomarkers, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2023-11-02

Completion Date

2029-08

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Sevasemten

Sevasemten is administered orally once per day

Locations (46)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

UC San Diego

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

UC Irvine Medical Center

Orange, California, United States

Stanford Neuroscience Health Center

Palo Alto, California, United States

UC Davis Medical Center

Sacramento, California, United States

UC Denver

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

Rare Disease Research

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Rochester Medical Center

Rochester, New York, United States

Rare Disease Research, LLC NC

Hillsborough, North Carolina, United States

University of Cincinnati Gardner Neuroscience Institute

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

National Neuromuscular Research Institute

Austin, Texas, United States

Neurology Rare Disease Center

Denton, Texas, United States

Virginia Commonwealth University Health

Richmond, Virginia, United States

University Hospital Gent

Ghent, Belgium, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium, Belgium

Centre Hospitalier Régional de la Citadelle

Liége, Belgium, Belgium

Rigshospitalet

Copenhagen, Denmark

Centre de Reference des Maladies Neuromusculaires et de la SLA - AP-HM Hopital de La Timone

Marseille, France, France

CHU de Nantes

Nantes, France, France

CHU de Nice - Hopital Pasteur 2 - Centre de reference des Maladies Neuromusculaires

Nice, France, France

AP-HP Hopital Pitie-Salpetriere

Paris, France, France

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

Munich, Germany, Germany

Hadassah University Hospital

Jerusalem, Israel

Fondazione IRCCS Ca'Granda Ospedale Maggiore

Milan, Italy, Italy

Azienda Ospedale - Università Padova

Padova, Italy, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Rome, Italy, Italy

Leids Universitair Medisch Centrum

Leiden, Netherlands

Hospital Universitario Vall d'Hebron

Barcelona, Spain, Spain

Hospital Universitario de Bellvitge

Barcelona, Spain, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Spain, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain, Spain

Salford Royal Hospital

Salford, United Kingdom, United Kingdom

University College London Hospital

London, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

Newcastle Freeman Hospital

Newcastle, United Kingdom