This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months

NCT03351244 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 1289-00492017-002369-23
• Study Type: interventional
• Target: 264
• Locations: 7 countries
• Sites: 59

Brief Summary

The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of First Relapse After 28 Weeks of Treatment

  The incidence rate of first relapse after 28 weeks of treatment is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

  28 weeks

Secondary Outcomes (6)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Symptoms Score After 28 Weeks of Treatment

  At baseline and at Week 28.

• Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 28 Weeks of Treatment

  At baseline and at Week 28

• Patient Global Impressions-Improvement (PGI-I) Scale Score After 28 Weeks of Treatment

  At Week 28

• Incidence Rate of Suicidal Ideation and Behaviour (Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)) After 28 Weeks of Treatment

  28 weeks

• Change From Baseline in Personal and Social Performance Scale (PSP) Score After 28 Weeks of Treatment

  At baseline and at Week 28

Study Arms (3)

BI 409306 50 mg

EXPERIMENTAL

1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Drug: BI 409306

BI 409306 25 mg

EXPERIMENTAL

1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Drug: BI 409306

Placebo

PLACEBO COMPARATOR

1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.

Drug: Placebo

Interventions

BI 409306 DRUG

28 week treatment period

BI 409306 25 mg; BI 409306 50 mg

Placebo DRUG

28 week treatment period

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) diagnosis of schizophrenia \>= one year prior to randomisation.
• Outpatients in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with treating clinician.
• Patients currently taking a stable dose of antipsychotic medication(s) for at least 12 weeks prior to randomisation.
• Detectable level of current antipsychotic medication(s) in plasma from blood drawn at Visit 1 (unless no assay is available for the antipsychotic(s) currently prescribed).
• Patients who have experienced at least 2 relapses within the past 5 years or at least 1 relapse if they were diagnosed less than 3 years ago. Relapse is defined as the patient having any of the following using the above number of relapses and time frames:
• Hospitalization for psychosis (involuntary or voluntary admission), intensive outpatient therapy or use of home treatment as an alternative to hospitalization (verified via medical record).
• Emergency Department visit for worsening schizophrenia symptoms (verified via medical record).
• Deliberate self-injury and/or violent behaviour resulting in significant injury to another person or property (verified by police record or treating mental health provider written record or documented phone conversation).
• Change in the patient's antipsychotic medication or increase in antipsychotic medication dosage due to worsening of schizophrenia symptoms (verified by pharmacy records or treating mental health provider written record or documented phone conversation).
• Clinical Global Impressions-Severity (CGI-S) score ≤4 at Visit 1 and 2.
• Positive and Negative Syndrome Scale (PANSS) total score \<80 and a score of ≤ 4 on individual PANSS items conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content at Visit 1.
• Of full age (according to local legislation, usually ≥ 18 years) and ≤ 55 years at the time of informed consent.
• Patients must have an identified informant who will be consistent throughout the study.
• Patients who report living at the same address for the 3 months prior to randomisation.
• Male or female patients.

You may not qualify if:

• Patients treated with more than two antipsychotic medications (including more than two dosage forms).
• Patients who are currently being treated with clozapine, or who have been treated with clozapine in the past 5 years.
• Patients with a categorical diagnosis of another current major psychiatric disorder per the Mini-international neuropsychiatric Interview (M.I.N.I.).
• Homicidal behaviour (in the investigator's judgement) in the past 2 years.
• Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
• Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
• In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial.
• Other known neurological diseases (including but not limited to any kind of seizures or stroke).
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
• Significant history of drug or alcohol dependence or abuse (Substance Use Disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or ICD-10) within the last six months prior to informed consent. (Not including caffeine or nicotine).
• Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
• Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the Investigator Site File (ISF)).
• Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF)
• Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (59)

Alea Research

Phoenix, Arizona, 85012, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Collaborative Neuroscience Network, LLC (CNS)

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Synergy East

Lemon Grove, California, 91945, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Excell Research Inc.

Oceanside, California, 92056, United States

Location

Orange County Neuropsychiatric Research Center LLC

Orange, California, 92868, United States

Location

Collaborative Neuroscience Network, LLC (CNS)

Torrance, California, 90502, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Reliable Clinical Research

Hialeah, Florida, 33012, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Behavioral Clinical Research, Inc.

North Miami, Florida, 33161, United States

Location

Meridien Research

Orlando, Florida, 32810, United States

Location

Atlanta Center

Atlanta, Georgia, 30331, United States

Location

Alam Medical Research, Inc.

Chicago, Illinois, 60612, United States

Location

Lake Charles Clinical Trials LLC

Lake Charles, Louisiana, 70629, United States

Location

Clinical Trials of America, LLC

Monroe, Louisiana, 71201, United States

Location

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

St. Charles Psychiatric Associates & Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Arch Clinical Trials

St Louis, Missouri, 63125, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

@Health Texas

Richmond, Texas, 77407, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, V2A 4M4, Canada

Location

The Medical Arts Health Research Group

Vancouver, British Columbia, V7T 1C5, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H4, Canada

Location

IUSMM Institut Universitaire en Sante Mentale de Montreal

Montreal, Quebec, H1N 3M5, Canada

Location

HOP la Colombière

Montpellier, 34295, France

Location

GHU Paris Psychiatrie et Neurosciences

Paris, 75674, France

Location

HOP Guillaume Régnier

Rennes, 35703, France

Location

HOP Nord

Saint-Priest-en-Jarez, 42270, France

Location

HOP Sainte Musse

Toulon, 83100, France

Location

Okehazama Hospital Fujita Kokoro Care Center

Aichi, Toyoake, 470-1168, Japan

Location

Fujita Health University Hospital

Aichi, Toyoake, 470-1192, Japan

Location

National Center for Global Health and Medicine Kohnodai Hospital

Chiba, Ichikawa, 272-8516, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kuramitsu Hospital

Fukuoka, Fukuoka, 819-0037, Japan

Location

Soushu Hospital

Kanagawa, Atsugi, 243-0201, Japan

Location

Kishiro Mental Clinic

Kanagawa, Kawasaki, 214-0014, Japan

Location

Nara Medical University Hospital

Nara, Kashihara, 634-8522, Japan

Location

National Hospital Organization Hizen Psychiatric Medical Center

Saga, Kanzaki-gun, 842-0192, Japan

Location

National Center Neurology and Psychiatry

Tokyo, Kodaira, 187-8851, Japan

Location

Chonnam National University Hospital

Gwangju, 61453, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

NCKUH

Tainan, 704, Taiwan

Location

Taoyuan Psychiatric Center

Taoyuan District, 33058, Taiwan

Location

Related Publications (1)

• Zhu Z, Roy D, Feng S, Vogler B. AI-based medication adherence prediction in patients with schizophrenia and attenuated psychotic disorders. Schizophr Res. 2025 Jan;275:42-51. doi: 10.1016/j.schres.2024.11.006. Epub 2024 Dec 4.

  PMID: 39637767 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Interventions

BI 409306

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The study was terminated due to sponsor decision. The planned number of participants to be recruited was not reached.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: December 7, 2017
• Primary Completion: March 10, 2021
• Study Completion: March 31, 2021
• Last Updated: May 14, 2025
• Results First Posted: April 4, 2022

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (10); ES (1); TW (2); KR (3); FR (5); US (32); CA (6)