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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003745-11 | EudraCT Number |
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This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.
Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.
Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.
The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iclepertin 10 mg | Experimental | Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iclepertin | Drug | One 10 milligram (mg) tablet once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Treatment Emergent Adverse Events (TEAEs) | Number of participants with treatment emergent adverse events. | From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT) | The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as [CGI-S EOT] - [CGI-S baseline] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe. |
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Inclusion criteria:
Exclusion criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Center, Inc. | Anaheim | California | 92805 | United States | ||
| Clinical Innovations, Inc |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Multi-center, multi-national, open label, single arm extension trial in patients with cognitive impairment due to schizophrenia who had completed 26 weeks of treatment with 10 milligrams (mg) iclepertin or matching placebo, taken once daily in one of the three Phase III (CONNEX) parent trials (trial 1346-0011, 1346-0012 or 1346-0013).
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| ID | Title | Description |
|---|---|---|
| FG000 | Iclepertin 10 mg | Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2023 | Feb 9, 2026 |
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| At baseline and at EOT. Up to a maximum of 60.1 weeks. |
| Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT) | Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as [last Hb on treatment] - [Hb baseline], is reported. | At baseline and at EOT. Up to a maximum of 60.1 weeks. |
| Bellflower |
| California |
| 90706 |
| United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California | 92845 | United States |
| Omega Clinical Trials,LLC | La Habra | California | 90631 | United States |
| ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California | 90807 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| ATP Clinical Research, Inc. | Orange | California | 92866 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| CNRI - Los Angeles | Pico Rivera | California | 90660 | United States |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | United States |
| Velocity Clinical Research, Santa Ana | Santa Ana | California | 92704 | United States |
| Stanford University Medical Center | Stanford | California | 94304 | United States |
| Collaborative Neuroscience Research | Torrance | California | 90504 | United States |
| Institute of Living | Hartford | Connecticut | 06106 | United States |
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
| Advanced Medical Research Group Inc | Hollywood | Florida | 33021 | United States |
| Accel Research Sites Network | Maitland | Florida | 32751 | United States |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33014 | United States |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | United States |
| Optimus U Corporation-Miami-69452 | Miami | Florida | 33135 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Nova Psychiatry Inc. | Orlando | Florida | 32803 | United States |
| Synexus Clinical Research-Atlanta-67262 | Atlanta | Georgia | 30328 | United States |
| American Medical Research | Chicago | Illinois | 60612 | United States |
| Sheppard Pratt Physicians's Practice Association, Inc. | Baltimore | Maryland | 21204 | United States |
| Center for Behavioral Health, LLC | Gaithersburg | Maryland | 20877 | United States |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | United States |
| Arch Clinical Trials, LLC | St Louis | Missouri | 63141 | United States |
| Omaha Insomnia and Psychiatric Services | Omaha | Nebraska | 68144 | United States |
| Hassman Research Institute-Marlton-66897 | Marlton | New Jersey | 08053 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| Richmond Behavioral Associates-Staten Island-68636 | Staten Island | New York | 10314 | United States |
| UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center | Raleigh | North Carolina | 27608 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Midwest Clinical Research | Dayton | Ohio | 45417 | United States |
| Insight Clinical Trials, LLC, Independence | Independence | Ohio | 44131 | United States |
| SP Research, PLLC | Oklahoma City | Oklahoma | 73112 | United States |
| University of Oregon Prevention Science Institute | Eugene | Oregon | 97403 | United States |
| Oasis Life Care | State College | Pennsylvania | 16801 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| JPS Center for Behavioral Health Recovery | Fort Worth | Texas | 76104 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| LinQ Research, LLC-Richmond-70076 | Richmond | Texas | 77407 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Clínica Privada Banfield | Banfield | B1828CKR | Argentina |
| CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.) | CABA | 1058AAJ | Argentina |
| Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM) | CABA | C1133AAH | Argentina |
| Fundación FunDaMos para la asistencia e investigación en psiquiatría | CABA | C1405BOA | Argentina |
| CEN (Centro Especializado Neurociencias) | Córdoba | 5004 | Argentina |
| Instituto Modelo de Neurología Lennox | Córdoba | X5000FAL | Argentina |
| Instituto Médico DAMIC S.R.L. | Córdoba | X5003DCE | Argentina |
| Sanatorio Morra S.A. | Córdoba | X5009 | Argentina |
| Instituto de Neurociencias San Agustín | La Plata | 1900 | Argentina |
| Global Psy Asociación Civil | La Plata | CP B1904AXQ | Argentina |
| Resolution Psychopharmacology Research Institute | Mendoza | 5502 | Argentina |
| Instituto Médico de la Fundación Estudios Clínicos | Rosario | 2000 | Argentina |
| Centro de Investigacion y Asistencia en Psiquiatria (CIAP) | Rosario | S2000QJI | Argentina |
| Centro Medico Luquez | San Vicente | X5006CBI | Argentina |
| Monash Alfred Psychiatry Research Centre | Melbourne | Victoria | 3004 | Australia |
| AKH - Medical University of Vienna | Vienna | 1090 | Austria |
| CUP Vivalia -La Clairière | Bertix | 6880 | Belgium |
| Sint-Kamillus | Bierbeek | 3360 | Belgium |
| Universitair Psychiatrisch Centrum Duffel (UPC Duffel) | Duffel | 2570 | Belgium |
| Meclinas | Mechelen | 2800 | Belgium |
| CPN - Centro de Estudos em Neurociências | Belo Horizonte | 30150-270 | Brazil |
| Hospital Sao Jose | Criciúma | 88811-000 | Brazil |
| Trial Tech- Tecnologia em pesquisa com medicamentos | Curitiba | 80.240-280 | Brazil |
| J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria | Goiânia | 74093-040 | Brazil |
| Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro | 22270-060 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | 09780-000 | Brazil |
| Hospital de Base - Fac Med de Sao Jose do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Cpquali Pesquisa Clinica Ltda | São Paulo | 01228-000 | Brazil |
| BR Trials | São Paulo | 01236-030 | Brazil |
| Clínica Viver - Centro de Desospitalização Humana | São Paulo | 04020-060 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo | 05403-903 | Brazil |
| Medical Center "Spectar" | Plovdiv | 4000 | Bulgaria |
| Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry | Plovdiv | 4002 | Bulgaria |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Centre for Addiction and Mental Health (CAMH) | Toronto | Ontario | M5T 1R8 | Canada |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Psicomed Estudios Clínicos | Segunda Región | 1270244 | Chile |
| The sixth People's Hospital of Hebei Province | Baoding | 71000 | China |
| Beijing Anding Hospital | Beijing | 100088 | China |
| Peking University Sixth Hospital | Beijing | 100089 | China |
| Beijing HuiLongGuan Hospital | Beijing | 100096 | China |
| The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province) | Changsha | 410007 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | 410011 | China |
| The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou | 510370 | China |
| The third affiliated hospital of Sun Yat-Sen University | Guangzhou | 510630 | China |
| Huzhou Third Municipal Hospital | Huzhou | 313000 | China |
| Shandong Daizhuang Hospital | Jining | 272051 | China |
| The First Affilliated Hospital Of Kunming of Medical College | Kunming | 650032 | China |
| Nanjing Brain Hospital | Nanjing | 210029 | China |
| The Affilicated Kangning Hospital of Ningbo University | Ningbo | 315201 | China |
| Shanghai Mental Health Center | Shanghai | 200030 | China |
| Tongji Hospital, Tongji University | Shanghai | 200065 | China |
| Shenzhen Kangning Hospital | Shenzhen | 518003 | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | 050030 | China |
| Tianjin Anding Hospital | Tianjin | 300222 | China |
| Wuxi mental health center | Wuxi | 214151 | China |
| First Affiliated Hospital of Xi'an JiaoTong University | Xi'an | 710061 | China |
| Xi'an Mental Health Center | Xi'an | 710101 | China |
| The Second Affiliated Hospital of Xinxiang Medical Univ. | Xinxiang | 453002 | China |
| Zhumadian Psychiatric Hospital | Zhumadian | 463000 | China |
| Centro de Investigación y Proyectos en neurociencia CIPNA | Barranquilla | 80020 | Colombia |
| E.S.E Hospital Mental de Antioquia | Bello | 51053 | Colombia |
| Instituto Colombiano del Sistema Nervioso- Clínica Montserrat | Bogotá | 110121 | Colombia |
| Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS | Bogotá | 111166 | Colombia |
| Psynapsis Salud Mental S.A. | Pereira | 660003 | Colombia |
| Clincal Hospital Centre Rijeka | Rijeka | 51 000 | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | 10 000 | Croatia |
| Solmed Polyclinic | Zagreb | 1000 | Croatia |
| Psychiatric Hospital 'Sveti Ivan' | Zagreb | 10090 | Croatia |
| University Psychiatric Hospital Vrapce | Zagreb | 10090 | Croatia |
| National Institute of Mental Health | Klecany | 25067 | Czechia |
| MP Meditrine s.r.o. | Ostrava | 70800 | Czechia |
| A-SHINE s.r.o | Pilsen | 30100 | Czechia |
| PRAGTIS s.r.o. | Prague | 120 00 | Czechia |
| INEP medical s.r.o. | Prague | 18600 | Czechia |
| Psychiatrie Ricany s.r.o. | Říčany | 251 01 | Czechia |
| Aalborg Universitetsshospital | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Psykiatrisk Center Glostrup | Glostrup Municipality | 2600 | Denmark |
| Aurora hospital | Helsinki | 00250 | Finland |
| CRST - Clinical Research Services Turku | Turku | 20520 | Finland |
| HOP Charles Perrens | Bordeaux | 33076 | France |
| HOP la Colombière | Montpellier | 34295 | France |
| HOP Hôtel-Dieu | Nantes | 44093 | France |
| Hôpital Pasteur | Nice | 06000 | France |
| HOP Carémeau | Nîmes | 30029 | France |
| HOP Guillaume Régnier | Rennes | 35703 | France |
| HOP Rouffach | Rouffach | 68250 | France |
| HOP Nord-Saint-Priest-en-Jarez-53664 | Saint-Priest-en-Jarez | 42270 | France |
| Zentrum für klinische Forschung Dr. med. I. Schöll GmbH | Bad Homburg | 61348 | Germany |
| Praxis Dr. Hahn, Berlin | Berlin | 13187 | Germany |
| Studienzentrum für Neurologie und Psychiatrie | Böblingen | 71034 | Germany |
| LWL-Klinik Dortmund | Dortmund | 44287 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Zentralinstitut für seelische Gesundheit | Mannheim | 68159 | Germany |
| Klinikum der Universität München AÖR | München | 80336 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Studienzentrum Nord-West | Westerstede | 26655 | Germany |
| Eginition Hospital | Athens | 11528 | Greece |
| "Attikon" University General Hospital of Attica | Chaïdári | 12462 | Greece |
| Psychiatric Hospital of Attica | Haidari | 12462 | Greece |
| AX Mental Health Clinic | Heraklion | 71305 | Greece |
| General Oncology Hospital "Agioi Anargyri" | Nea Kifissia | 14564 | Greece |
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | 54636 | Greece |
| General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki | 57 010 | Greece |
| Semmelweis University | Budapest | 1082 | Hungary |
| ASST degli Spedali Civili di Brescia | Brescia | 25123 | Italy |
| A.O. Fatebenefratelli | Milan | 20121 | Italy |
| Ist. San Raffaele Turro | Milan | 20127 | Italy |
| Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano (TO) | 10043 | Italy |
| A.O.U. Senese | Siena | 53100 | Italy |
| Hotei Hospital | Aichi, Konan | 483-8248 | Japan |
| Okehazama Hospital Fujita Kokoro Care Center | Aichi, Toyoake | 470-1168 | Japan |
| Toyota Memorial Hospital | Aichi, Toyota | 471-8513 | Japan |
| National Hospital Organization Shimofusa Psychiatric Medical Center | Chiba, Chiba | 266-0007 | Japan |
| Japan Institute for Health Security National Kohnodai Medical Center | Chiba, Ichikawa | 272-8516 | Japan |
| Uematsu Mental Clinic | Fukuoka, Chikugo | 833-0041 | Japan |
| Mental Clinic Sakurazaka | Fukuoka, Fukuoka | 810-0023 | Japan |
| AK Clinic | Fukuoka, Fukuoka | 810-0031 | Japan |
| Fukuoka University Hospital | Fukuoka, Fukuoka | 814-0180 | Japan |
| Kuramitsu Hospital | Fukuoka, Fukuoka | 819-0037 | Japan |
| Hirota Clinic | Fukuoka, Kurume | 830-0033 | Japan |
| Shiranui Hospital | Fukuoka, Omuta | 836-0004 | Japan |
| Kishi Hospital | Gumma, Kiryu | 376-0011 | Japan |
| Obihiro-Kosei General Hospital | Hokkaido, Obihiro | 080-0024 | Japan |
| Hokudai-dori Mental Health Clinic | Hokkaido, Sapporo | 001-0010 | Japan |
| Hokkaido University Hospital | Hokkaido, Sapporo | 060-8648 | Japan |
| Tatsuta Clinic | Hyogo, Kobe | 651-0097 | Japan |
| Kanazawa Medical University Hospital | Ishikwa, Kahoku-gun | 920-0293 | Japan |
| Kishiro Mental Clinic | Kanagawa, Kawasaki | 214-0014 | Japan |
| St. Marianna University Hospital | Kanagawa, Kawasaki | 216-8511 | Japan |
| Links Mental Clinic | Kanagawa, Yokohama | 224-0001 | Japan |
| Yokohama Onoecho Clinic | Kanagawa, Yokohama | 231-0015 | Japan |
| Hino Hospital | Kanagawa, Yokohama | 234-0051 | Japan |
| Yokohama City University Hospital | Kanagawa, Yokohama | 236-0004 | Japan |
| Kochi Health Sciences Center | Kochi, Kochi | 781-8555 | Japan |
| Yuge Neuropsychiatric Hospital | Kumamoto, Kumamoto | 861-8002 | Japan |
| Medical Corporation Yamadakai Yatsushiro Welfare Hospital | Kumamoto, Yatsushiro | 866-0043 | Japan |
| National Hospital Organization Maizuru Medical Center | Kyoto, Maizuru | 625-8502 | Japan |
| Tohoku University Hospital | Miyagi, Sendai | 980-8574 | Japan |
| Shounan Hospital | Nagano, Matsumoto | 390-0847 | Japan |
| Suwa Red Cross Hospital | Nagano, Suwa | 392-8510 | Japan |
| Nara Medical University Hospital | Nara, Kashihara | 634-8522 | Japan |
| Niigata University Medical and Dental Hospital | Niigata, Niigata | 951-8520 | Japan |
| University of the Ryukyus Hospital | Okinawa, Ginowan | 901-2725 | Japan |
| Osaka City Hospital Organization Osaka City General Hospital | Osaka, Osaka | 534-0021 | Japan |
| National Hospital Organization Hizen Psychiatric Medical Center | Saga, Kanzaki-gun | 842-0192 | Japan |
| Rainbow and Sea Hospital | Saga, Karatsu | 847-0031 | Japan |
| Inuo Hospital | Saga, Tosu | 841-0081 | Japan |
| Nishi Kumagaya Hospital | Saitama, Kumagaya | 360-0816 | Japan |
| Sho Midori Hospital | Saitama, Saitama | 336-0022 | Japan |
| Dokkyo Medical University Hospital | Tochigi, Shimotsuga-gun | 321-0293 | Japan |
| Tokushima University Hospital | Tokushima, Tokushima | 770-8503 | Japan |
| Medical Corporation Seijin Hospital | Tokyo, Adachi-ku | 121-8515 | Japan |
| Institute of Science Tokyo Hospital | Tokyo, Bunkyo-ku | 113-8519 | Japan |
| Nishigahara Hospital | Tokyo, Kita-ku | 114-0024 | Japan |
| National Center of Neurology and Psychiatry | Tokyo, Kodaira | 187-8851 | Japan |
| Asuka Hospital | Tokyo, Machida | 194-0005 | Japan |
| Minami-Aoyama Antique Street Clinic | Tokyo, Minato-ku | 107-0062 | Japan |
| Toho University Omori Medical Center | Tokyo, Ota-ku | 143-8541 | Japan |
| Maynds Tower Mental Clinic | Tokyo, Shibuya-ku | 151-0053 | Japan |
| Shinjuku East Mental Clinic | Tokyo, Shinjuku-ku | 160-0021 | Japan |
| Ohwa Mental Clinic | Tokyo, Toshima-ku | 170-0002 | Japan |
| Hokuriku Hospital | Toyama, Nanto | 939-1893 | Japan |
| Yamaguchi University Hospital | Yamaguchi, Ube | 755-8505 | Japan |
| University of Yamanashi Hospital | Yamanashi, Chuo | 409-3898 | Japan |
| JSC Romuvos Clinic | Kaunas | LT-44279 | Lithuania |
| LUHS KH Psichiatric Clinic Mariu Division | Kaunas | LT-53137 | Lithuania |
| JSC Medical center "Puriena" | Šilutė | LT-99142 | Lithuania |
| Vilnius City Mental Health Center | Vilnius | LT-10309 | Lithuania |
| Hospital Raja Permaisuri Bainun | Ipoh, Perak | 30450 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Sentosa | Kuching | 93250 | Malaysia |
| Hospital Tuanku Ja'afar | Seremban | 70300 | Malaysia |
| Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. | Culiacán | 80230 | Mexico |
| Clinica Cemelli | Guadalajara | 44660 | Mexico |
| Hospital Aranda de la Parra | León | 37000 | Mexico |
| Centro de Investigación Clinica Acelerada, S.C. | Mexico City | 07369 | Mexico |
| GabiPros S.C. | Mexico City | 07810 | Mexico |
| Instituto Nacional de Neurologia y Neurocirugia | Mexico City | 14269 | Mexico |
| Medical Care & Research SA de CV | Mérida | 97070 | Mexico |
| Iecsi S.C. | Monterrey | 64310 | Mexico |
| CIT-Neuropsique S.C | Monterrey | 64610 | Mexico |
| Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME). | Monterrey | 64710 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Nuevo León | 64460 | Mexico |
| BIND Investigaciones S.C. | San Luis Potosí City | 78213 | Mexico |
| Universitair Medisch Centrum Groningen | Groningen | 9713 AV | Netherlands |
| North Shore Hospital | Takpuna Auckland | 0622 | New Zealand |
| Sykehuset Østfold HF, avd. Moss | Moss | N-1535 | Norway |
| Akershus universitetssykehus Oslo | Oslo | 0963 | Norway |
| Philippine General Hospital | Manila, Philippines | 1000 | Philippines |
| Psychiatric Doctor's Office Ireneusz Kaczorowski | Bełchatów | 97-400 | Poland |
| Podlassian Center of Psychogeriatry, Bialystok | Bialystok | 15-756 | Poland |
| Health Center Alcea | Gdansk | 80-283 | Poland |
| MentalMEDIC | Gliwice | 44100 | Poland |
| Central Clinical Hospital of the Medical University of Lodz | Lodz | 92-216 | Poland |
| Individual Specialist Medical Practice Filip Rybakowski | Poznan | 60-744 | Poland |
| EUROMEDIS Sp. z o.o., Szczecin | Szczecin | 70-111 | Poland |
| Institute of Psychiatry and Neurology in Warsaw | Warsaw | 02-957 | Poland |
| Clinhouse | Zabrze | 41-807 | Poland |
| ULS da Região de Leiria, E.P.E. | Leiria | 2410-197 | Portugal |
| Mental Health Center Sector 4 | Bucharest | 040872 | Romania |
| SC Carpe Diem SRL | Sibiu | 557260 | Romania |
| Clinical Hospital Center Dr. Dragisa Misovic | Belgrade | 11000 | Serbia |
| General Hospital Euromedik | Belgrade | 11000 | Serbia |
| Institute for Mental Health | Belgrade | 11000 | Serbia |
| Special Hospital for Psychiatric Diseases Gornja Toponica | Gornja Toponica | 18202 | Serbia |
| Special Hospital for Psychiatric Diseases Sveti Vračevi | Novi Kneževac | 23330 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | 21000 | Serbia |
| Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach | Bojnice | 97201 | Slovakia |
| EPAMED s.r.o. | Košice | 040 01 | Slovakia |
| Psychiatricka Ambulancia Psycholine s.r.o. | Rimavská Sobota | 97901 | Slovakia |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Chonnam National University Hospital | Gwangju | 61453 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 626-770 | South Korea |
| Hestia Palau | Barcelona | 08025 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario General de Villalba | Collado de Villalba | 28400 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Centro de Salud de San Juan | Salamanca | 37005 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Nicolás Peña | Vigo | 36211 | Spain |
| Hospital Provincial. Complejo Asistencial de Zamora | Zamora | 49021 | Spain |
| Psykiatriska Kliniken | Helsingborg | 20153 | Sweden |
| Akademiska sjukhuset | Uppsala | 751 85 | Sweden |
| Kai-Syuan Psychiatric Hospital | Kaohsiung City | 802 | Taiwan |
| Chang Gung Memorial Hospital-Keelung | Keelung | 204 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| NCKUH | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Taoyuan Psychiatric Center | Taoyuan | 33058 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 330 | Taiwan |
| Hacettepe Universitesi Tip Fakultesi | Ankara | 06230 | Turkey (Türkiye) |
| Ankara University Medical School | Ankara | 06590 | Turkey (Türkiye) |
| Istanbul University | Istanbul | 34093 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Psikiyatri A.B.D. | Izmir | 35340 | Turkey (Türkiye) |
| Celal Bayar Universitesi Tip Fakultesi | Manisa | 45030 | Turkey (Türkiye) |
| Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council | Nove | 25491 | Ukraine |
| Bodmin Community Hospital | Bodmin | PL31 2QT | United Kingdom |
| The Fritchie Centre | Cheltenham | GL53 9DZ | United Kingdom |
| Redesmere | Chester | CH2 1BQ | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Maudsley Hospital | London | SE5 8AZ | United Kingdom |
| Warneford Hospital | Oxford | OX3 7JX | United Kingdom |
| Moorgreen Hospital | Southampton | SO30 3JB | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iclepertin 10 mg | Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurence of Treatment Emergent Adverse Events (TEAEs) | Number of participants with treatment emergent adverse events. | Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication. | Posted | Count of Participants | Participants | From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT) | The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as [CGI-S EOT] - [CGI-S baseline] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe. | Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication. Patients without values at EOT were excluded from the analysis. | Posted | Mean | Standard Deviation | Units on a scale | At baseline and at EOT. Up to a maximum of 60.1 weeks. |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT) | Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as [last Hb on treatment] - [Hb baseline], is reported. | Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication. Patients without a Hb value on-treatment were excluded from the analysis. | Posted | Mean | Standard Deviation | grams/liter | At baseline and at EOT. Up to a maximum of 60.1 weeks. |
|
|
All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iclepertin 10 mg | Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily. | 2 | 1,356 | 82 | 1,356 | 261 | 1,356 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Chemical burns of eye | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Inflammatory pseudotumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Primary mediastinal large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Impulsive behaviour | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Self-destructive behaviour | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Family stress | Social circumstances | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
As per protocol, end of treatment was planned for Week 52. Forty-nine patients stayed longer on treatment (protocol deviation), up to a maximum of 60.1 weeks.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2025 | Feb 9, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634404 | BI 425809 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|