BI 425809 and placebo in patients with Schizophrenia.

• Research type

  Research Study

• Full title

  A phase II randomised, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 425809 once daily over 12 week treatment period in patients with Schizophrenia.

• IRAS ID

  204214

• Contact name

  Jill Paterson

• Contact email

  jill.paterson@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2016-000285-28

• Duration of Study in the UK

  1 years, 2 months, 13 days

• Research summary

  The title of this study is "A phase II randomised, double-blinded, placebo-controlled parallel group trial to
  examine the efficacy and safety of 4 oral doses of BI 425809 once daily over 12 week treatment period in patients with Schizophrenia". Primary objectives of this trial are to provide proof of concept and dose finding data in patients with schizophrenia on stable antipsychotic treatment who are treated with oral once daily administration of BI 425809 or placebo. Other objectives of this trial are to assess the safety and pharmacokinetics of BI 425809. It is hoped that 504 participants worldwide will enter the study with 84 patients receiving study medication and 168 receiving placebo. Each patients participation is expected to last approximately 5 months and will require 7 visits to the study clinic. The study will use 10 tests which will assess 7 aspects of cognition, including speed of processing, attention and vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.

• REC name

  West of Scotland REC 1

• REC reference

  16/WS/0156

• Date of REC Opinion

  16 Sep 2016

• REC opinion

  Unfavourable Opinion