Draft Qualification Opinion for Stride Velocity 95th Centile as Primary Endpoint in Studies in Ambulatory Duchenne Muscular Dystrophy Studies

1 March 2023 – the EMA published the draft qualification opinion for the Stride Velocity 95th centile (SV95C) as primary endpoint in superiority studies.

The SV95C is a clinical outcome assessment (COA) captured by using a digital and passive wearable device and system that was developed by the Applicant. The primary purpose of this request is to seek qualification of the SV95C for use as a primary endpoint in clinical trials from Phase 1 to Phase 4 for the measurement of the maximal stride velocity in real-life of ambulant patients with DMD.

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