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Study identifier: NCT05933057 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Duchenne Muscular Dystrophy  ·  Sponsor: Italfarmaco

PhasePhase 3
Planned participants138
Who can joinMale, 9 Years to 17 Years
Healthy volunteersNo

About this study

This 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)

This description comes directly from the study's public registry record.

Talk to the study team

Italfarmaco Patient Advocacy  ·  +39 02 6443 1  ·  patientadvocacy@italfarmacogroup.com

Always discuss trial participation with your own doctor first.

Locations (29)

Universitaire Ziekenhuizen LeuvenLeuven, BelgiumRecruiting
British Columbia Children's HospitalVancouver, British Columbia, CanadaRecruiting
The University of Western Ontario - Children's Health Research InstituteLondon, Ontario, CanadaRecruiting
University of Ottawa - Children's Hospital of Eastern OntarioOttawa, Ontario, CanadaRecruiting
University of Toronto - Holland Bloorview Kids Rehabilitation HospitalToronto, Ontario, CanadaRecruiting
Klinika dětské neurologie 2. LF, Fakultní nemocnice v MotolePrague, CzechiaNot Yet Recruiting
Centre Hospitalier Régional Universitaire de LilleLille, FranceRecruiting
Centre hospitalier universitaire - Hôpitaux de MarseilleMarseille, FranceRecruiting
Hôpital Armand-Trousseau - I-MotionParis, FranceRecruiting
Charite-Universitaetsmedizin BerlinBerlin, GermanyRecruiting
Universitätsklinikum Essen Kinder-und Jugendmedizin NeuropadiatrieEssen, GermanyNot Yet Recruiting
Universitaetsklinikum FreiburgFreiburg im Breisgau, GermanyRecruiting

+ 17 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05933057