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A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

Study acronym: EXPEDITION
StatusEnrolling by Invitation
PhasePhase 3
Started2023-09-27
View on ClinicalTrials.gov ↗

Amendment history

2026-02-04
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v13
Primary completion date2030-11-30→2033-10-31
Completion date2030-11-30→2033-10-31
Study sites37→38
Eligibility criteria-171 characters
[...] le and all other protocol requirements. Exclusion Criteria: ParticipantNot or family does not want to disclose participation with general practitioner/primary care physician and other medical providers. Other inclusion/exclusion criteria may apply.applicable
Secondary endpoints9 entries, revised
Change in the North Star Ambulatory Assessment (NSAA) Total Score From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec to the End of the Study Participation Change in Time to Rise From Floor From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec to the End of the Study Participation Change in the Time of 10-meter Walk/Run (10MWR) From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec to the End of the Study Participation Change in Performance of Upper Limb (PUL) (Version 2.0) Total Scores From Pre-infusion [...] [...]
2025-01-15
minor
Study Status, Contacts/Locations v12
Study sites36→37
2024-12-13
minor
Study Status, Contacts/Locations v11
Study sites34→36
2024-11-15
minor
Study Status, Contacts/Locations v10
Study sites31→34
2024-10-18
minor
Study Status, Contacts/Locations v9
Study sites27→31
Show 8 earlier versions
2024-09-17
minor
Study Status, Contacts/Locations v8
Study sites21→27
2024-08-01
minor
Study Status, Contacts/Locations v7
Study sites15→21
2024-06-20
minor
Study Status, Contacts/Locations v6
Study sites11→15
2024-05-15
minor
Study Status, Contacts/Locations v5
Study sites7→11
2024-04-19
minor
Study Status, Contacts/Locations v4
Study sites5→7
2024-02-21
minor
Study Status, Contacts/Locations v3
Study sites4→5
2023-12-20
minor
Study Status, Contacts/Locations v2
Study sites2→4
2023-10-26
notable
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2023-08-31→confirmed 2023-09-27
Study sitescontacts updated at 2 of 2 sites
2023-07-21
minor
Original filing
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.
Trial Details
NCT Number NCT05967351
Lead Sponsor Sarepta Therapeutics, Inc.
Collaborators: Hoffmann-La Roche
Conditions Duchenne Muscular Dystrophy
Enrollment 400 participants
Start Date 2023-09-27
Primary Completion 2033-10-31 (estimated)
Study Completion 2033-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-06