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An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy

Study acronym: ENDURE
StatusEnrolling by Invitation
PhaseNot specified
Started2024-02-07
View on ClinicalTrials.gov ↗

Amendment history

2026-04-28
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v12
Eligibility criteria+292 characters
Inclusion Criteria: Has aan definitiveestablished clinical diagnosis of DMD prior to Screening based on documentation of clinical findings and prior confirmatory genetic testing using a clinical diagnostic genetic test. Is currently receiving or has been prescribed to start chr [...] therapy at the time of this observational study enrollment. AFor participantELEVIDYS-treated recruitedParticipants to (Cohorts 1a, 1b, and 1c): Is at least 4 years of age at the time of infusion Will either: a) be initiating or has initiated ELEVIDYS within the last 30 days in routine clinical practice at the time of thi [...] [...]
Secondary endpoints8 to 11 entries
Performance of Upper Limb (PUL) Version 2.0 Entry Item A Score or Brooke Upper Extremity Scale Score Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity, and Fatigue Pulmonary Function, as Measured by Forced Vital Capacity (FVC) Pulmonary Function as Measured by FVC Percent Predicted (FVC% Predictedp) Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF), as Measured by Echocardiogram (ECHO) or Cardiac MRI (cMRI) Number of Participants Experiencing Treatment-emergentSerious AdverseALI Eventsand Acute Liver Failure (TEAEsALF) Num [...] [...]
Primary endpoints1 to 2 entries
Number of Participants Experiencing Acute Liver Injury (ALI)
Study title+11 characters
An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy
2025-11-28
Study Status, Contacts/Locations v11
Study sites22→25
2025-10-03
Study Status, Contacts/Locations v10
Study sites19→22
2025-08-08
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v9
Trial statusRecruiting→Enrolling by Invitation
Study sites17→19
2025-07-03
Study Status, Contacts/Locations v8
Study sites15→17
Show 7 earlier versions
2025-04-30
Study Status, Contacts/Locations v7
Study sites13→15
2024-11-27
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Study sites9→13
InterventionsStandard of Care (Drug), delandistrogene moxeparvovec (Genetic)→Delandistrogene Moxeparvovec (Genetic), Standard of Care (Drug)
Eligibility criteria+12 characters
Inclusion Criteria: - Has a definitive diagnosis of DMD prior to Screening based o [...] tion of clinical findings and confirmatory genetic testing. AmongIs participantscurrently receiving or has been prescribed to start chronic glucocorticoid therapy at the time of this observational study enrollment. A participant recruited fromto routineCohorts clinical1a practiceor 2: Is agedat least 4 throughyears 5of yearsage at the time of enrollment. Is ambulatory per protocol specified criteria. IsA currentlyparticipant receiving or has been prescribedrecruited to startCohort chronic1b: - glucocorticoidIs th [...] [...]
Secondary endpoints9 to 8 entries
All Cohorts: Time to Rise From Floor (Supine to Stand) All Cohorts: Loss of Ambulation (LOA) All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item A Score All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue All Cohorts: Pulmonary Function, as Measured by Forced Vital Capacity (FVC) (% Predicted) All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO) All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Del [...] [...]
Primary endpoints1 entry, revised
All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and10MWR) (Calculated Velocity) at Month 12
2024-08-30
Study Status, Contacts/Locations v5
Study sites6→9
2024-07-12
Study Status, Contacts/Locations v4
Study sites5→6
2024-05-24
Study Status, Contacts/Locations v3
Study sites4→5
2024-04-11
Study Status, Contacts/Locations v2
Study sites1→4
2024-03-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-29→confirmed 2024-02-07
Study sitesdetails revised at 1 of 1 site
2024-02-13
Original filing
This is a multicenter, prospective, observational Phase 4 study including a post marketing safety requirement, designed to collect both medical history data and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec (ELEVIDYS) as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at the time of study enrollment in routine clinical practice.
Trial Details
NCT Number NCT06270719
Lead Sponsor Sarepta Therapeutics, Inc.
Conditions Duchenne Muscular Dystrophy
Enrollment 500 participants
Start Date 2024-02-07
Primary Completion 2029-12-31 (estimated)
Study Completion 2038-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-04