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

Sarepta Therapeutics

Status and phase: Invitation-only; Phase 3

Conditions: Duchenne Muscular Dystrophy

Treatments: Genetic: delandistrogene moxeparvovec

Study type: Interventional

Funder types: Industry

Identifiers

NCT05967351

SRP-9001-305

2023-505043-39-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Delandistrogene Moxeparvovec

Experimental group

Description:

Participants received delandistrogene moxeparvovec in a previous clinical study.

Treatment:

Genetic: delandistrogene moxeparvovec