Clinical Trials List
Protocol Number1346.9
NCT Number(ClinicalTrials.gov Identfier)NCT02832037
2018-05-04 - 2020-12-31
Phase II
Terminated4
ICD-10F20
Schizophrenia
A phase II randomized, 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
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim, Taiwan
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chen-Chung Liu Division of Psychiatry
- YI-TING LIN Division of Psychiatry
- CHIH-MIN LIU Division of Psychiatry
- 謝明憲 Division of Psychiatry
- YI-LING CHIEN Division of Psychiatry
The Actual Total Number of Participants Enrolled
5 Stop recruiting
Co-Principal Investigator
- 楊凱鈞 Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Po-Yu Chen Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張維紘 Division of Psychiatry
- 陳高欽 Division of Psychiatry
- Po-See Chen Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
CRO
Condition/Disease
Patients with established Schizophrenia (as per DSM-5) who are clinically stable
Objectives
The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Test Drug
BI 425809
Active Ingredient
BI 425809
Dosage Form
table
Dosage
1, 5, 25
Endpoints
Primary Outcome Measures :
Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment [ Time Frame: Baseline, after 6 and 12 weeks of treatment ]
Secondary Outcome Measures :
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment [ Time Frame: Baseline and after 12 weeks of treatment ]
Percentage of Participants With Any Adverse Event [ Time Frame: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days ]
Percentage of participants with any Adverse Event.
Change From Baseline in Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment [ Time Frame: Baseline, after 6 and 12 weeks of treatment ]
Secondary Outcome Measures :
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment [ Time Frame: Baseline and after 12 weeks of treatment ]
Percentage of Participants With Any Adverse Event [ Time Frame: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days ]
Percentage of participants with any Adverse Event.
Inclution 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:
Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation
Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation
patients who have no more than a moderate severe rating on the Positive and Negative Symptom Scale (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:
patients may have up to 2 antipsychotics (typical and/or atypical)
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
patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepileptics 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
Men or women who are 18-50 years (inclusive) of age at time of consent
Established schizophrenia with the following clinical features:
Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation
Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation
patients who have no more than a moderate severe rating on the Positive and Negative Symptom Scale (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:
patients may have up to 2 antipsychotics (typical and/or atypical)
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
patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepileptics 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
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 Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) assessments within the last 6 months
Patients who required change in 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 randomization
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 report
Hemoglobin less than 120 g/L (12g/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 (except for Benzodiazepines taken according to prescription and as an ongoing, stable regimen)
Further exclusion criteria apply
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 Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) assessments within the last 6 months
Patients who required change in 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 randomization
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 report
Hemoglobin less than 120 g/L (12g/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 (except for Benzodiazepines taken according to prescription and as an ongoing, stable regimen)
Further exclusion criteria apply
The Estimated Number of Participants
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Taiwan
20 participants
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Global
504 participants
