1346-0009: BI425809 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
Sponsor organisation
Boehringer Ingelheim
Eudract number
2016-000285-28
Duration of Study in the UK
1 years, 1 months, 30 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 clinical 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 84x4:336 patients receiving the study medication,84 on each of the dosage groups (2mg, 5mg,10mg, 25mg daily)and 168 receiving placebo. Each patients participation is expected to last approximately 5 months and will require 7 visits to the study clinic. The primary endpoint will be assessed using the MCCB test to evaluate cognitive functions, this is made up of 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
18/WS/0040
Date of REC Opinion
3 Apr 2018
REC opinion
Further Information Favourable Opinion