A Long-term Follow-up Study of Participants Who Received Elevidys in a Previous Clinical Study (EXPEDITION)
Study Overview
- Age
- 2 years and older
- Phase
- Interventional
- Sponsor
- Sarepta Therapeutics
- Therapeutic Approach
- Gene Therapy
- Variant Requirement
- The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received Elevidys in a previous clinical study. No study drug will be administered as part of this study.
- Eligible Sex
- Male
- Ambulation
- Ambulatory and Non-Ambulatory
- Study Start (Actual)
- 2023-09-27
- Primary Completion (Estimated)
- 2033-10-31
- Study Completion (Estimated)
- 2033-10-31
- Enrollment (Estimated)
- 400
- Countries
- United StatesBelgiumGermanyHong KongItalyJapanSpainTaiwanUnited Kingdom
Study Requirements and Criteria
Inclusion Criteria
- Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.
- Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.
Exclusion Criteria
Not applicable
Contacts and Locations
Contacts and Locations
Locations
This study has 38 locations
United States
Arkansas Locations
Little Rock, Arkansas, United States, 72202
Arkansas Children's Hospital
California Locations
Los Angeles, California, United States, 90095
UCLA Medical Center
Palo Alto, California, United States, 94304
Lucile Packard Children's Hospital Stanford (LPCH)
Sacramento, California, United States, 95817
University of California, Davis
San Diego, California, United States, 92123
Rady Children's Hospital
Colorado Locations
Aurora, Colorado, United States, 80045-7106
Children's Hospital of Colorado
Florida Locations
Gainesville, Florida, United States, 32610
University of Florida Clinical Research Center
Illinois Locations
Chicago, Illinois, United States, 60611
Ann & Robert H. Lurie Children's Hospital of Chicago
Iowa Locations
Iowa City, Iowa, United States, 52242
University of Iowa ICTS Clinical Research Unit
Maryland Locations
Baltimore, Maryland, United States, 21287
The Johns Hopkins Hospital, Rubenstein Child Health Bldg
Massachusetts Locations
Boston, Massachusetts, United States, 02115
Boston Children's Hospital
Missouri Locations
St Louis, Missouri, United States, 63110
Washington University School of Medicine
New York Locations
New York, New York, United States, 10032
Columbia University Pediatric Neuromuscular Center
Rochester, New York, United States, 14642
University of Rochester Medical Center
North Carolina Locations
Durham, North Carolina, United States, 27705
Lenox Baker Children's Hospital (Duke University)
Ohio Locations
Columbus, Ohio, United States, 43205
Nationwide Children's Hospital
Oregon Locations
Portland, Oregon, United States, 97239
Oregon Health and Science University
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19104
Chiildren's Hospital of Philadelphia
Texas Locations
Dallas, Texas, United States, 75207
Children's Health Specialty Center
Utah Locations
Salt Lake City, Utah, United States, 84132
University of Utah Health
Virginia Locations
Norfolk, Virginia, United States, 23510
Children's Hospital of The King's Daughters
Wisconsin Locations
Milwaukee, Wisconsin, United States, 53226
Children's Hospital Wisconsin
Belgium
East Flanders Locations
Ghent, East Flanders, Belgium, 9000
Universitair Ziekenhuis Gent, Neuromuscular Reference Centre (NMRC)
Germany
North Rhine-Westphalia Locations
Essen, North Rhine-Westphalia, Germany, 45147
Universitätsklinikum Essen - Klinik für Kinderheilkunde I
Hong Kong
Hong Kong, Hong Kong
Hong Kong Children's Hospital
Italy
Genova, Italy, 16147
UOC Neurologia Pediatrica e Malattie Muscolari, Istituto G. Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico
Milan, Italy, 20122
UOC Neurologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Roma, Italy, 00168
UOC Neuropsichiatria Infantile, Area Salute del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattoclica del Sacro Cuore
Japan
Hyōgo Locations
Kobe, Hyōgo, Japan, 650-0017
Kobe University Hospital
Tokyo Locations
Kodaira, Tokyo, Japan, 187-8551
National Center of Neurology and Psychiatry
Tokyo, Japan, 1628666
Tokyo Women's Medical University Hospital
Spain
Barcelona Locations
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Sant Joan de Deu
Valencia, Spain, 46026
Hospital Universitario y Politecnico La fe. Neurology Department
Taiwan
Kaohsiung City, Taiwan, 807
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taipei, Taiwan, 100225
National Taiwan University Hospital
United Kingdom
Greater London Locations
London, Greater London, United Kingdom, WC1N 1EJ
Great Ormond Street Hospital For Children NHS Foundation Trust
Oxfordshire Locations
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Oxford University Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 3BZ
Institute of Translational and Clinical Research
Clinical Trial Registry
NCT ID
NCT05967351This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.