Givinostat DMD long term study

• Research type

  Research Study

• Full title

  Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies.

• IRAS ID

  261557

• Contact name

  Michela Guglieri

• Contact email

  michela.guglieri@newcastle.ac.uk

• Sponsor organisation

  ITALFARMACO S.p.A.

• Eudract number

  2017-000397-10

• Clinicaltrials.gov Identifier

  126598, IND Number

• Duration of Study in the UK

  5 years, 6 months, 1 days

• Research summary

  The main aim of this study is to formally assess the long term safety and tolerability of GIVINOSTAT oral suspension in patients with Duchenne Muscular Dystrophy (DMD).
  To evaluate the effects of long-term administration of GIVINOSTAT on muscular function and strength, respiratory function and the impact on daily activities and the quality of life following long-term administration of GIVINOSTAT.

  This long term study aims to continue monitoring signs of efficacy of GIVINOSTAT in this patients’ population until the Marketing Authorization will be granted and the product will become available.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  19/NE/0263

• Date of REC Opinion

  20 Jan 2020

• REC opinion

  Further Information Favourable Opinion