Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder

• IRAS ID

  116465

• Contact name

  Andrea Cavanna

• Sponsor organisation

  Otsuka Pharmaceutical Development & Commercialization, Inc.

• Eudract number

  2012-003488-23

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Aripiprazole (OPC-14597) is being studied as a possible treatment for Tourette’s Disorder. The reason for this study is to find out the potential benefits and safety of aripiprazole and compare it with a placebo in children and adolescents with Tourette’s disorder. About 126 participants from about 120 centres around the world will be joining in this study. Subject participation will last approximately between 12.5 weeks to 18 weeks which includes a screening period, a treatment period and a follow-up period.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  13/WM/0002

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion