1346-0014 Long-term safety of BI 425809 in people with schizophrenia
Research type
Research Study
Full title
An open label, single arm, extension trial to examine long-term safety of BI 425809 once daily in patients with schizophrenia who have completed previous BI 425809 Phase III trials.(CONNEX-X)
IRAS ID
299552
Contact name
Richard Laugharne
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2020-003745-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 10 months, 24 days
Research summary
This is a multi-centre, multi-national, open label, single arm extension trial in patients with cognitive impairment due to schizophrenia who have completed 26 weeks of treatment with 10 mg BI 425809 or matching placebo, taken once daily in one of the three phase III parent trials (trial 1346-0011, 1346-0012 or 1346-0013).
Patients may be enrolled in this trial once the patient has signed the informed consent form and determined to have met all entry criteria for protocol 1346-0014. Patients must have a study partner. This is someone able to understand the trial related procedures, who knows the patient well and has been capable of interacting with the patient on a regular basis. Its preferred that this is the same person throughout the study.
Patients previously on active treatment in parent trial will continue to receive BI 425809 treatment and patients who were randomized to placebo in the parent trial will start receiving BI 425809 for the first time at Visit 1. Patients will receive treatment for 1 year. After completion of the open label treatment, patients will have a 4-week safety follow-up.
In addition to the collection of AEs, patients will be required to undergo regular safety blood tests and complete a number of assessments to monitor for symptoms and patient reported outcomes.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0052
Date of REC Opinion
3 May 2022
REC opinion
Further Information Favourable Opinion