ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02832037
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: BI 425809 dose 1 Drug: BI 425809 dose 2 Drug: BI 425809 dose 3 Drug: BI 425809 dose 4 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Randomised, 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
Actual Study Start Date : July 25, 2016
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: BI 425809 dose 1 Drug: BI 425809 dose 1
Drug: Placebo
Experimental: BI 425809 dose 2 Drug: BI 425809 dose 2
Drug: Placebo
Experimental: BI 425809 dose 3 Drug: BI 425809 dose 3
Drug: Placebo
Experimental: BI 425809 dose 4 Drug: BI 425809 dose 4
Drug: Placebo
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in cognitive function as measured by the total score of the composite Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score after 12 weeks of treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 12 weeks of treatment [ Time Frame: 12 weeks ]
  2. Percentage of patients with (Serious) Adverse Events (including clinically relevant abnormalities of physical examination, vital signs, Electrocardiogram (ECG) test and laboratory tests) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832037


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 71 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02832037     History of Changes
Other Study ID Numbers: 1346.9
2016-000285-28 ( EudraCT Number )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders