Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old

PHASE2RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 2, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

Givinostat Hydrochloride

Cohort 1 - from 4 to 6 years old

DRUG

Givinostat Hydrochloride - Cohort 2

Cohort 2 - from 2 to 4 years old

Trial Locations (9)

1020

RECRUITING

Queen Fabiola Children's University Hospital HUDERF, Brussels

20162

RECRUITING

Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - NeuroMuscolar Omnicenter, Milan

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Roma

RECRUITING

Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore, Roma

2300 RC

RECRUITING

Leids Universitair Medisch Centrum (LUMC), Leiden

Unknown

NOT_YET_RECRUITING

Leeds Teaching Hospital NHS Trust, Leeds

NOT_YET_RECRUITING

Great Ormond Street Hospital - GOSH, London

NE1 eBZ

RECRUITING

Newcastle upon Tyne Hospitals NHS Foundation Trust - Newcastle University, Newcastle upon Tyne

OX3 9DU

RECRUITING

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Fortrea

INDUSTRY

lead

Italfarmaco

INDUSTRY

NCT06769633 - Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Old | Biotech Hunter | Biotech Hunter