A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
Public ClinicalTrials.gov record NCT05096221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study. The participants who are randomized to the placebo arm will have an opportunity for treatment with gene transfer therapy at the beginning of the second year.
Study identification
- NCT ID
- NCT05096221
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 7 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2021 (Actual)
- Primary completion
- Oct 4, 2023 (Actual)
- Completion
- Oct 25, 2024 (Actual)
- Last update posted
- Jul 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 23
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's | Little Rock | Arkansas | 72202 | — |
| UC San Diego Altman Clinical and Translational Research Institute | La Jolla | California | 92037 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Lucile Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| University of Florida | Gainesville | Florida | 32608 | — |
| Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Iowa Stead Family Children's Hospital | Iowa City | Iowa | 52242 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Washington University of St. Louis | St Louis | Missouri | 63110 | — |
| Columbia University/NYPH | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Duke University Medical Center, Lenox Baker Children's Hospital | Durham | North Carolina | 27705 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43210 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23510 | — |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05096221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05096221 live on ClinicalTrials.gov.