Clinical Trial

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

Study acronym: ULYSSES
Recruiting Phase 3
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Summary
This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to \<18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. * Planned screening duration: approximately 4 weeks (±14 days) * Planned treatment duration: 18 months (approximately 72 weeks) * Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study) * Total duration of study participation: up to 83 weeks (ie, 20-21 months)
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-06-27; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2024-02-20
Trial Details
NCT Number NCT05933057
Lead Sponsor Italfarmaco
Collaborators: Fortrea
Conditions Duchenne Muscular Dystrophy
Enrollment 138 participants
Start Date 2024-02-19
Primary Completion 2028-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-24