A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy

This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years of follow-up.

NCT Number	NCT07127978
Lead Sponsor	ITF Therapeutics LLC
Conditions	Duchene Muscular Dystrophy
Enrollment	300 participants
Start Date	2025-10-23
Primary Completion	2030-06-30 (estimated)
Study Completion	2030-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-02