Clinical Trial

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2017-12-11; most recent amendment 2026-01-19.
Status change: Active, Not Recruiting → Recruiting 2026-01-19
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-04-29
Status change: Recruiting → Enrolling by Invitation 2020-09-18
Trial Details
NCT Number NCT03373968
Lead Sponsor Italfarmaco
Collaborators: Cromsource
Conditions Duchenne Muscular Dystrophy
Enrollment 206 participants
Start Date 2017-10-24
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-21