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Delandistrogene Moxeparvovec for Duchenne Muscular Dystrophy (ENDURE Trial)

N/A
Recruiting
Research Sponsored by Sarepta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

ENDURE Trial Summary

This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies.

Eligible Conditions
  • Duchenne Muscular Dystrophy

ENDURE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12
Secondary outcome measures
All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO)
All Cohorts: Loss of Ambulation (LOA)
All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
+6 more

ENDURE Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Participants unexposed to DMD gene therapy receiving standard of care therapy (chronic glucocorticoid treatment) that does not include delandistrogene moxeparvovec or other DMD gene therapies.
Group II: Delandistrogene MoxeparvovecExperimental Treatment1 Intervention
Participants were either (1) prescribed delandistrogene moxeparvovec commercially as part of clinical care prior to entry into this trial or (2) previously received delandistrogene moxeparvovec through participation in select SRP-9001 studies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
delandistrogene moxeparvovec
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Sarepta Therapeutics, Inc.Lead Sponsor
49 Previous Clinical Trials
33,039 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy
2024. "An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270719.
All > Paid Studies Baltimore > Fort Worth
~333 spots leftby Dec 2029
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