schizophrenia MedDRA version: 20.0 Level: LLT Classification code 10039632 Term: Schizophrenia NOS System Organ Class: 100000004873
Conditions
Interventions
Product Code: BI 425809
Pharmaceutical Form: Tablet
Current Sponsor code: BI 425809
Other descriptive name: BI 425809
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients who are 18-50 years (inclusive) of age at time of consent 2. Established schizophrenia DSM-5 with the following clinical features: -Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomization -Psychiatrically stable without symptom exacerbation within 3 months prior to randomization -PANSS score = 5 on positive items P1, P3-P7 and = 4 on positive item P2 at Visit 1, and confirmed at Visit 2 3. Patients must be on stable antipsychotic treatment; also, current antipsychotic medications and concomitant anticholinergics, antiepileptics, lithium and allowed antidepressants must meet the criteria below: -Patients must take 1 and may take up to 2 antipsychotics (typical and/or atypical), except for clozapine -Patients must be stable on current antipsychotics, anticholinergics, antiepileptics, lithium and allowed antidepressants for at least 3 months prior to randomization and be on current dose for at least 30 days prior to randomization --Patients on long-acting injectable (LAI) antipsychotics should be on the same medication and dose for at least 3 months prior to randomization 4. Patients must demonstrate their ability to properly use the CCT device and program, as well as be compliant with CCT run-in 5. Patients must have a study partner who will preferably be consistent throughout the study Further criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have a categorical diagnosis of another current major psychiatric disorder on the M.I.N.I. 2. Patients with a history of participating in any formal cognitive remediation program for 10 or more training sessions 3. Patients who were treated with any of the following medications within the last 6 months prior to randomization: -Bitopertin, BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia -Clozapine (atypical antipsychotic medication) -Sarcosine, cycloserine, serine and glycine -Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil) -Tricyclic antidepressants 4. Patients who have participated in a clinical trial with repeated assessments (i.e. a single assessment is not exclusionary) with the MCCB within the last 6 months prior to randomization 5. Significant history of drug abuse disorder within the last 6 months prior to informed consent, or a positive urine drug screen at Visit 1 6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to provide PoC data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive CCT.;Secondary Objective: Other objectives of this trial are to explore endpoints to assess functioning and well-being of patients with schizophrenia, and to evaluate safety and pharmacokinetics of BI 425809.;Primary end point(s): 1) Change from baseline in neurocognitive function as measured by the neurocognitive composite score of the MCCB;Timepoint(s) of evaluation of this end point: 1) 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change from baseline in cognitive function as measured by the overall MCCB composite score (including social cognition) 2) Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score after 12 weeks of treatment 3) Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score 4) Percentage of patients with (S)AEs;Timepoint(s) of evaluation of this end point: 1) 12 weeks 2) 12 weeks 3) 12 weeks 4) whole trial | — |
Countries
Australia, Canada, France, New Zealand, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed