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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02832037
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : February 12, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 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
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : January 29, 2020

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.


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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


Locations
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United States, California
Collaborative Neuroscience Network, LLC (CNS)
Garden Grove, California, United States, 92845
Synergy San Diego
Lemon Grove, California, United States, 91945
NRC Research Institute
Orange, California, United States, 92868
Alliance for Wellness
Panorama City, California, United States, 91402
CNRI - Los Angeles
Pico Rivera, California, United States, 90660
CNRI-San Diego, LLC
San Diego, California, United States, 92102
United States, Florida
Premier Clinical Research Institute
Miami, Florida, United States, 33122
United States, Georgia
Synexus
Atlanta, Georgia, United States, 30328
Atlanta Center
Atlanta, Georgia, United States, 30331
United States, Illinois
Uptown Research Institute
Chicago, Illinois, United States, 60640
United States, Louisiana
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, United States, 70629
United States, Michigan
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Mid-America Clinical Research, LLC
Saint Louis, Missouri, United States, 63109
United States, New York
University at Buffalo, The State University of New York
Buffalo, New York, United States, 14215
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
North Carolina Psychiatric Research Center
Raleigh, North Carolina, United States, 27610
United States, Ohio
Midwest Clinical Research
Dayton, Ohio, United States, 45417
United States, Texas
InSite Clinical Research
DeSoto, Texas, United States, 75115
United States, Utah
Psychiatric and Behavioral Solutions, LLC
Salt Lake City, Utah, United States, 84105
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Austria
Medical University of Innsbruck
Innsbruck, Austria, 6020
AKH - Medical University of Vienna
Vienna, Austria, 1090
Canada, British Columbia
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, Canada, V2A 4M4
The Medical Arts Health Research Group
Vancouver, British Columbia, Canada, V7T 1C5
Canada, Ontario
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada, N7L 1C1
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M5T 1R8
Canada, Quebec
IUSMM Institut Universitaire en Sante Mentale de Montreal
Montreal, Quebec, Canada, H1N 3M5
Canada
IUSMQ
Quebec, Canada, G1J 2G3
Germany
Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen
Bad Homburg, Germany, 61348
Praxis Dr. med. Volker Schumann
Berlin, Germany, 10245
Berufsausübungsgemeinschaft, Dr. sc. med. Alexander Schulze und Prof. Dr. med. Hagen Kunte
Berlin, Germany, 13156
Praxis Dr. Hahn, Berlin
Berlin, Germany, 13187
PANAKEIA Arzneimittelforschung Leipzig GmbH
Leipzig, Germany, 04275
Zentralinstitut für seelische Gesundheit
Mannheim, Germany, 68159
Neurologie und Psychiatrie / Psychotherapie
Westerstede, Germany, 26655
Italy
ASST degli Spedali Civili di Brescia
Concesio (BS), Italy, 25062
Asst Santi Paolo E Carlo
Milano, Italy, 20142
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano (TO), Italy, 10043
Japan
Fujita Health University Hospital
Aichi, Toyoake, Japan, 470-1192
Chiba University Hospital
Chiba, Chiba, Japan, 260-8677
National Center for Global Health and Medicine Kohnodai Hospital
Chiba, Ichikawa, Japan, 272-8516
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan, 807-8556
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Kobe University Hospital
Hyogo, Kobe, Japan, 650-0017
Kagawa University Hospital
Kagawa, Kita-gun, Japan, 761-0793
Kishiro Mental Clinic
Kanagawa, Kawasaki, Japan, 214-0014
Nara Medical University Hospital
Nara, Kashihara, Japan, 634-8522
Kansai Medical University Medical Center
Osaka, Moriguchi, Japan, 570-8507
Iwaki Clinic, Tokushima, Psychosomatic Medicine
Tokushima, Anan, Japan, 774-0014
National Center Neurology and Psychiatry
Tokyo, Kodaira, Japan, 187-8851
Showa University Karasuyama Hospital
Tokyo, Setagaya, Japan, 157-8577
Tokyo Women's Medical University Hospital
Tokyo, Shinjuku-ku, Japan, 162-8666
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 61453
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital
Seoul, Korea, Republic of, 03722
National Center for Mental Health
Seoul, Korea, Republic of, 04933
Asan Medical Center
Seoul, Korea, Republic of, 05505
Poland
Wlokiennicza Med,Spec.Med.Prac,MD Tomasz Markowski,Bialystok
Bialystok, Poland, 15 464
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, Poland, 15-756
Osrodek Badan Klinicznych CLINSANTE S.C.
Bydgoszcz, Poland, 85794
Non-public Health Care Psychiatric Institution MENTIS,Leszno
Leszno, Poland, 64100
EUROMEDIS Sp. z o.o., Szczecin
Szczecin, Poland, 70-111
Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
Torun, Poland, 87-100
Therapy Centre DIALOG Sp.z o.o. S.j.
Warszawa, Poland, 02-791
Spain
Hospital del Mar
Barcelona, Spain, 08003
Centro de Salud Mental de Fuencarral
Madrid, Spain, 28029
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Puerta de Hierro
Majadahonda (Madrid), Spain, 28222
Centro de Salud de San Juan
Salamanca, Spain, 37005
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Taiwan
NCKUH
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 10016
Taipei City Hospital
Taipei, Taiwan, 110
Taipe Veterans General Hospital
Taipei, Taiwan, 11217
United Kingdom
Bushey Fields Hospital
Dudley, United Kingdom, DY1 2LZ
Royal Edinburgh Hospital
Edinburgh, United Kingdom, EH10 5HF
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
King's College Hospital
London, United Kingdom, SE5 8AF
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3HD
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02832037    
Other Study ID Numbers: 1346.9
2016-000285-28 ( EudraCT Number )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders