NCT05967351Enrolling by invitationPhase 3
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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 delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 27 Sept 2023
- Primary completion date
- 31 Oct 2033
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT05967351
- EU CT number
- 2023-505043-39-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 27 Sept 2023 to the primary completion date, 31 Oct 2033
- 38 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not applicable
Who the study is looking for
- 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.
Age in the registry: - to 64 years · Sex: Male · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Great Ormond Street Hospital For Children NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Institute of Translational and Clinical Research Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Hong Kong Children's Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Giannina Gaslini Institute For Scientific Hospitalization And Care Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Kodaira | Japan | Unknown status |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Children's Hospital of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| The Johns Hopkins Hospital, Rubenstein Child Health Bldg Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Children's Health Specialty Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Lenox Baker Children's Hospital (Duke University) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Florida Clinical Research Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| University of Iowa ICTS Clinical Research Unit Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Columbia University Pediatric Neuromuscular Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Lucile Packard Children's Hospital Stanford (LPCH) Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Chiildren's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University Of Utah Health Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.