BI 425809 with brain training in patients with schizophrenia
Research type
Research Study
Full title
A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily with adjunctive Computerized Cognitive Training over 12 week treatment period in patients with schizophrenia
IRAS ID
254209
Contact name
Ken Scrine
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2018-002740-82
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 9 months, 8 days
Research summary
The study will recruit 200 participant through 25 sites based between Australia, Canada, France, Ireland. New Zealand, UK and the USA
Participants are included in the study only once the informed consent has been signed.
There will be an initial screening period where as well as initial assessment for inclusion and exclusion criteria participants will undergo Computerised Brain Training (CCT) for two weeks. Those participants who meet eligibility criteria and comply wth the 2 week CCT training will be stratified by age ( age 18-40 and age 41-50) and allocated at random to one of the two study groups for the 12 week treatment period. These groups are active drug (10mg + CCT) or matching placebo + CCT. The treatment period will be followed by a 4 week follow-up period. This follow up period will also be applicable following discontinuation.
Eligible patients will attend 7 clinic based visits over 12 weeks. Screening Visit 1 and 2 and EoT visit may be split across two days at the discretion of the investigator.
During study visits patients will have their medical history recorded, undergo a routine physical examination, vital signs, height and weight measured, have a standard ECG, routine blood and urine tests, blood samples taken for PK analysis and undergo a series of assessment interviews and tests. At-home adjunctive CCT will be used in this study to provide background cognitive stimulation to the patients. Patients’ routine treatment and care plan will remain otherwise unchanged.REC name
South Central - Oxford C Research Ethics Committee
REC reference
19/SC/0084
Date of REC Opinion
6 Mar 2019
REC opinion
Favourable Opinion