Italfarmaco — Biomedical Watch V2

Traitements2programmes

Essais1liés

Publications2liées

SourceDBlocale

Traitements

2

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
GivinostatThis 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)	Myopathies	Phase 3	À vérifier	Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, …	À vérifier
GivinostatThis 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)	Myopathies	Phase 3	À vérifier	Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, Serbia, Spain, Sweden, United Kingdom	À vérifier

Essais cliniques

1

Molécule	Indication / population	Phase	NCT	Titre	Statut
Givinostat	Myopathies	Phase 3	NCT05933057	ULYSSES — Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy	RECRUITING

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Givinostat		Real-world safety profile of givinostat: an early post-marketing pharmacovigilance study based on the FAERS database.	Frontiers in pharmacology
Givinostat		From design to clinic: Medicinal chemistry and pharmacology of approved epigenetic drugs.	European journal of medicinal chemistry