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ACTIVE NOT RECRUITING
NCT04475926

A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice

Sponsor: Sarepta Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1). These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 5 years after enrollment for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a North Star Assessment for Dysferlinopathy (NSAD) ≥ 25 at Baseline, up to 3 years for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a NSAD \< 25 at Baseline, and up to 3 years for participants with LGMD2A/R1. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.

Official title: Journey: A Global, Multicenter, Longitudinal Study of the Natural History of Subjects With Limb Girdle Muscular Dystrophy (LGMD) Type 2E (LGMD2E/R4), Type 2D (LGMD2D/R3), Type 2C (LGMD2C/R5), and Type 2A (LGMD2A/R1)

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

OBSERVATIONAL

Enrollment

205

Start Date

2021-04-22

Completion Date

2030-09-05

Last Updated

2025-11-06

Healthy Volunteers

No

Locations (26)

Barrow Neurological Institute

Phoenix, Arizona, United States

Arkansas Children's

Little Rock, Arkansas, United States

University of California San Diego

La Jolla, California, United States

University of California, Davis Health Dept of PM&R

Sacramento, California, United States

Anne & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

University Hospital Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Children's Hospital - London Health Science Centre

London, Ontario, Canada

Zentrum für Kinderheilkunde und Jugendmedizin Uniklinikum Giessen Marburg (UKGM), Standort Giessen

Giessen, Hesse, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Istituto Giannina Gaslini

Genoa, Liguria, Italy

Azienda Ospedale Università Padova

Padova, Veneto, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Hospital Sant Joan de Déu Universidad de Barcelona

Barcelona, Spain

Karolinska Universitetssjukhuset Solna

Stockholm, Stockholm County, Sweden

Lokman Hekim Etlik Hastanesi

Ankara, Turkey (Türkiye)

UCL Institute of Child Health & Great Ormond Street Hospital for Children

London, United Kingdom

Institute of Genetic Medicine, International Centre for Life

Newcastle upon Tyne, United Kingdom