Clinical trial of BI 425809 effect on cognition and functional capacity in schizophrenia

Phase 1

Conditions: Patients with schizophrenia on stable antispychotic treatment
MedDRA version: 19.0 Level: LLT Classification code 10039634 Term: Schizophrenia residual System Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2016-000285-28-AT

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 720

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 0

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 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, Hepatitis B or C infection
- Hemoglobin less than 130 g/L (13g/dL) in men or 120g/L (12g/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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to provide proof of concept (PoC) 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;<br> 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<br> ;<br> Timepoint(s) of evaluation of this end point: 1: 12 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> <br> 2: Percentage of patients with (Serious)Adverse Evetns (including clinically relevant abnormalities of physical examination, vital signs, Electrocardiogram (ECG) test and laboratory tests)<br> ;<br> Timepoint(s) of evaluation of this end point: 1: 12 weeks<br> <br> 2: 12 weeks<br>

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