Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old
Recruiting now · Phase 2
Conditions studied: Duchenne Muscular Dystrophy
In brief
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)
Key facts
- Study ID
- NCT06769633
- Run by
- Italfarmaco
- People needed
- 18
- Starts
- 2025-01-02
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2025-07-10
Who can join
Age: 2 and older, up to 6. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Oxford University Hospitals NHS Foundation Trust — Oxford, England, United Kingdom (enrolling)
- Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - NeuroMuscolar Omnicenter — Milan, Italy (enrolling)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (enrolling)
- Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore — Roma, Italy (enrolling)
- Leids Universitair Medisch Centrum (LUMC) — Leiden, Netherlands (enrolling)
- Newcastle upon Tyne Hospitals NHS Foundation Trust - Newcastle University — Newcastle upon Tyne, England, United Kingdom (enrolling)
- Queen Fabiola Children's University Hospital HUDERF — Brussels, Belgium (enrolling)
- Leeds Teaching Hospital NHS Trust — Leeds, England, United Kingdom
- Great Ormond Street Hospital - GOSH — London, England, United Kingdom
Full record on ClinicalTrials.gov
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