Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

This is a Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in younger DMD Patients. * Planned screening duration: approximately 4 weeks * Planned Core Treatment duration: approximately 48 weeks * Planned Extension Treatment duration: approximately 96 weeks * Planned Follow Up duration: approximately 4 weeks (± 7 days) * Total duration of study participation: up to 151 weeks (ie, 37-38 months)

NCT Number	NCT06769633
Lead Sponsor	Italfarmaco Collaborators: Fortrea
Conditions	Duchenne Muscular Dystrophy
Enrollment	18 participants
Start Date	2025-01-02
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2025-07-10