Patients with schizophrenia on stable antispychotic treatment MedDRA version: 20.0 Level: LLT Classification code 10039634 Term: Schizophrenia residual System Organ Class: 100000004873
Conditions
Interventions
Product Name: BI 425809/5 mg
Product Code: BI 425809
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Current Sponsor code: BI 425809
Other descriptive name: BI 425809
Concentration unit
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women who are 18-50 years (inclusive) of age at time of consent. - Established schizophrenia with the following clinical features: a) Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation; b) Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation; c) patients who have no more than a moderate severe rating on the PANSS positive items P1, P3-P7 and no more than a moderate rating on the PANSS positive item P2. - Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1 must meet the criteria below: a) patients may have up to 2 antipsychotics (typical and/or atypical); b) patients must be maintained on current typical and/or atypical antipsychotics other than Clozapine and on current dose for at least 4 weeks prior to randomisation and/or maintained on current long acting injectable antipsychotics and current dose for at least 3 months prior to randomization; c) patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepilectics and/or lithium for at least 3 months prior to randomisation and on current dose for at least 4 weeks prior to randomisation. - Women of child-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. - Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures, in the investigator´s opinion. - Patients must have an identified informant who will be consistent throughout the study. -Further inclusion criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 504 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients who have a categorical diagnosis of another current major psychiatric disorder. - Diseases of the central nervous system that may impact cognitive test performance. - Movement disorder not currently controlled. - Patients receiving another investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or recent participation in another trial with any cognitive enhancing therapy. - Recent participation in formal cognitive remediation program. - Recent electroconvulsive therapy. - Patients who have been on BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia within the last 6 months prior to randomisation or who have previously been on bitopertin. - Participation in a clinical trial with repeated MATRICS Consensus Cognitive Battery (MCCB) assessments within the last 6 months. - Patients who required change in their ongoing stable benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation. - Treatment with Clozapine within 6 months prior to randomisation. - Treatment with medical devices (e.g. Transcranial Magnetic Stimulation (TMS), neurofeedback) for any psychiatric condition within the last 3 months prior to randomisation. - Patients taking strong or moderate Cytochrome P450 (CYPA4) inhibitors or inducers within the last 30 days prior to randomisation. - Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to randomisation. - Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) prior to randomisation. - Known history of Human Immunodeficiency Virus (HIV) infection, and/or a positive result for ongoing Hepatitis B or C infection on the Visit 1 central lab. - Hemoglobin less than 120 g/L (12 g/dL) in men or 115 g/L (11.5 g/dL) in women. -History of hemoglobinopathy such as thalassemia major or sickle-cell anemia. - Women who are pregnant, nursing, or who plan to become pregnant while in the trial or men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of the study participation and for at least 28 days after treatment has ended. - Significant history of drug abuse disorder (including alcohol) within the last 6 months prior to informed consent or a positive urine drug screen at screening. - Further exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide proof of clinical concept (PoCC) 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;Secondary Objective: to assess the safety and pharmacokinetics of BI 425809;Primary end point(s): 1: Change from baseline in cognitive function as measured by the composite MATRICS Consensus Cognitive Battery (MCCB) score after 12 weeks of treatment ;Timepoint(s) of evaluation of this end point: 1: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 12 weeks of treatment 2: Percentage of patients with (Serious)Adverse Evetns (including clinically relevant abnormalities of physical examination, vital signs, Electrocardiogram (ECG) test and laboratory tests) ;Timepoint(s) of evaluation of this end point: 1: 12 weeks 2: 12 weeks | — |
Countries
Austria, Canada, Germany, Italy, Japan, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim GmbH & Co. KG
Outcome results
None listed