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A Long-term Follow-up Study of Participants Who Received Elevidys in a Previous Clinical Study (EXPEDITION)
Enrolling by InvitationInterventionalGene Therapy
Study Overview
- Age
- 2 years and older
- Phase
- Interventional
- Sponsor
- Sarepta Therapeutics
- Therapeutic Approach
- Gene Therapy
- Variant Requirement
- 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 Elevidys in a previous clinical study. No study drug will be administered as part of this study.
- Eligible Sex
- Male
- Ambulation
- Ambulatory and Non-Ambulatory
- Study Start (Actual)
- 2023-09-27
- Primary Completion (Estimated)
- 2033-10-31
- Study Completion (Estimated)
- 2033-10-31
- Enrollment (Estimated)
- 400
- Countries
- United StatesBelgiumGermanyHong KongItalyJapanSpainTaiwanUnited Kingdom
Study Requirements and Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
Not applicable
Clinical Trial Registry
NCT ID
NCT05967351This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.