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Be Part of Research - Trial Details - Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Not Recruiting

Open to: MALE

Age: 7.0 - N/A

Medical Conditions

Duchenne Muscular Dystrophy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2017 Dec 2029

Publications

"McDonald CM, Guglieri M, Vucinic D, Acsadi G, Brandsema JF, Bruno C, Finanger EL, Harper A, Lobato ML, Masson R, Muelas N, Munell F, Nevo Y, Pereon Y, Phan H, Sansone VA, Scoto M, Willis T, Finkel RS, Vandenborne K, Cazzaniga S, Montrasio S, Alessi F, Bettica P, Mercuri E; Givinostat Study 51 Investigators; Cooperative International Neuromuscular Research Group (CINRG) Duchenne Natural History Study (DNHS) Investigators; ImagingDMD Investigators. Long-Term Evaluation of Givinostat in Duchenne Muscular Dystrophy, and Natural History Comparisons. Ann Clin Transl Neurol. 2025 Aug 19. doi: 10.1002/acn3.70165. Online ahead of print."; "40830818"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : suspension of givinostat (10 mg/mL)

Intervention Arm Group : givinostat;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Alder Hey Children's Hospital NHS Trust
    Liverpool
    UK
    L12 2AP
  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    Gobowen
    SY10 7AG
  • UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD
    London
    , WC1N 1EH
  • The John Walton Muscular Dystrophy Research Centre
    Newcastle upon Tyne
    NE1 3BZ


The study is sponsored by Italfarmaco and is in collaboration with Cromsource.




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Read full details for Trial ID: NCT03373968
Last updated 29 April 2025

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