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Givinostat long-term extension in DMD
NCT03373968Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2017
- Primary completion
- Dec 2029
- Countries
- 11
- Sponsor
- Italfarmaco
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules
- Drugs
- givinostat
- Conditions
- Duchenne muscular dystrophy (DMD)
01
Overview
Phase 3, open-label, single-arm trial of givinostat in Duchenne muscular dystrophy (DMD), sponsored by Italfarmaco. Primary endpoint: Treatment-Emergent Adverse Events at 1 year. Started Oct 2017; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Givinostat
Open-label givinostat oral suspension (10 mg/mL) administered twice daily in fed state, with weight-based dose adjustments
03
Who it enrols
DMD patients aged ≥6 years who previously participated in givinostat studies, with adequate hematologic, renal, hepatic, and cardiac function, and no significant uncontrolled comorbidities
04
Endpoints
Primary
Treatment-Emergent Adverse Events
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