Open RECLAIM Safety&Efficacy Study of TEV-50717 in DCP in Pediatric

• Research type

  Research Study

• Full title

  An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)

• IRAS ID

  271167

• Contact name

  Daniel Lumsden

• Contact email

  Daniel.Lumsden@gstt.nhs.uk

• Sponsor organisation

  Teva Branded Pharmaceutical Products R&D, Inc.

• Eudract number

  2019-001807-19

• Clinicaltrials.gov Identifier

  139700, IND Number:

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This study is an extension of the study from TV50717-CNS-30080, which is a randomised control trial of TEV-50717. Only patients who have already taken part in TV50717-CNS-30080 will be offered the chance to enrol in this continuing study, to help us determine if the continue to benefit from this medication

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  20/SC/0026

• Date of REC Opinion

  25 Mar 2020

• REC opinion

  Further Information Favourable Opinion