NCT05933057 - Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy | Biotech Hunter

Enrollment

138

Participants

Timeline

Start Date

February 19, 2024

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

Conditions

Duchenne Muscular Dystrophy

Interventions

DRUG

Givinostat

Givinostat has to be administered twice daily in a fed state according to a flexible dose regimen based on patient weight. Starting dose could be reduced based on predefined safety rules.

DRUG

Placebo

Placebo, manufactured to mimic givinostat, has to be administered twice daily in a fed state according to a flexible dose regimen based on patient weight. Starting dose could be reduced based on predefined safety rules.

Trial Locations (20)

3000

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

10117

RECRUITING

Charite-Universitaetsmedizin Berlin, Berlin

13385

RECRUITING

Centre hospitalier universitaire - Hôpitaux de Marseille, Marseille

20162

RECRUITING

Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - NeuroMuscular Omnicentre, Milan

23842

RECRUITING

Associazione La Nostra Famiglia - IRCCS Eugenio Medea - Bosisio Parini, Lecco

35128

RECRUITING

Università degli Studi di Padova - Azienda Ospedaliera di Padova, Padua

53113

RECRUITING

Universitaetsklinikum Freiburg, Freiburg im Breisgau

59037

RECRUITING

Centre Hospitalier Régional Universitaire de Lille, Lille

75935

RECRUITING

Hôpital Armand-Trousseau - I-Motion, Paris

V6H 3V4

RECRUITING

British Columbia Children's Hospital, Vancouver

N6A 5W9

RECRUITING

The University of Western Ontario - Children's Health Research Institute, London

K1H 8L1

RECRUITING

University of Ottawa - Children's Hospital of Eastern Ontario, Ottawa

M4G 1R8

RECRUITING

University of Toronto - Holland Bloorview Kids Rehabilitation Hospital, Toronto

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

6500 HB

RECRUITING

Radboud Universitair Medisch Centrum (Radboudumc), Nijmegen

NE1 3BZ

ACTIVE_NOT_RECRUITING

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

OX3 9DU

WITHDRAWN

Oxford University Hospitals NHS Foundation Trust, Oxford

G51 4TF

ACTIVE_NOT_RECRUITING

NHS Greater Glasgow and Clyde - Royal Hospital for Children, Glasgow