Duchenne Muscular Dystrophy Clinical Trial
Official title:
Phaseout DMD: A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation With Ezutromid in Ambulatory Paediatric Male Subjects With Duchenne Muscular Dystrophy (SMT C11005)
To Assess the Activity and Safety of SMT C1100 (Ezutromid) in Paediatric Male Participants with Duchenne Muscular Dystrophy (DMD).
This is a Phase 2, open label, study to assess the activity and safety of utrophin modulation
with SMT C1100 (ezutromid) administered twice-daily orally in ambulatory paediatric male
participants with DMD.
This study will be conducted in a multi-centre setting in both the United Kingdom and the
United States of America and comprises of a Screening and Baseline Phase of up to 28 days, a
48-week open label Treatment Phase, and either a 30-day Safety Follow up Phase or an optional
extension phase where study treatment is provided until discontinuation of the program or
regulatory approvals as applicable.
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