Schizophrenia Clinical Trial
Official title:
An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)
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.
| Status | Recruiting |
| Enrollment | 1401 |
| Est. completion date | February 24, 2026 |
| Est. primary completion date | February 6, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 51 Years |
| Eligibility | Inclusion criteria: - Signed and dated written informed consent. - Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)). - Patients, who completed participation in the parent trial. - Women of childbearing potential must use highly effective methods of birth control. - Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply. Exclusion criteria: - Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase III trial. - Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study. - Positive urine drug screen = 3 times during the treatment period of parent trial. - Patients who are currently or wish to participate in another investigational drug trial. - Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial. Further exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Clínica Privada Banfield | Banfield | |
| Argentina | CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.) | Caba | |
| Argentina | Fundación FunDaMos para la asistencia e investigación en psiquiatría | Caba | |
| Argentina | Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM) | Caba | |
| Argentina | CEN (Centro Especializado Neurociencias) | Cordoba | |
| Argentina | Instituto Médico DAMIC S.R.L. | Cordoba | |
| Argentina | Instituto Modelo de Neurología Lennox | Córdoba | |
| Argentina | Sanatorio Morra S.A. | Córdoba | |
| Argentina | Clinica Privada de Salud Mental Santa Teresa de Avila | La Plata | |
| Argentina | Instituto de Neurociencias San Agustín | La Plata | |
| Argentina | Resolution Psychopharmacology Research Institute | Mendoza | |
| Argentina | Centro de Investigacion y Asistencia en Psiquiatria (CIAP) | Rosario | |
| Argentina | Instituto Médico de la Fundación Estudios Clínicos | Rosario | |
| Argentina | Centro Medico Luquez | San Vicente | |
| Australia | Monash Alfred Psychiatry Research Centre | Melbourne | Victoria |
| Belgium | CUP Vivalia -La Clairière | Bertix | |
| Belgium | Universitair Psychiatrisch Centrum Duffel (UPC Duffel) | Duffel | |
| Brazil | CPN - Centro de Estudos em Neurociências | Belo Horizonte | |
| Brazil | Hospital Sao Jose | Criciuma | |
| Brazil | Trial Tech- Tecnologia em pesquisa com medicamentos | Curitiba | |
| Brazil | J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria | Goiania | |
| Brazil | Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro | |
| Brazil | CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | |
| Brazil | Hospital de Base - Fac Med de Sao Jose do Rio Preto | Sao Jose do Rio Preto | |
| Brazil | BR Trials | Sao Paulo | |
| Brazil | Clínica Viver - Centro de Desospitalização Humana | Sao Paulo | |
| Brazil | Cpquali Pesquisa Clinica Ltda | São Paulo | |
| Brazil | Hospital das Clinicas da FMUSP | São Paulo | |
| Canada | University of Calgary | Calgary | Alberta |
| Chile | Biomedica Research Group | Santiago | |
| Chile | Psicomed Estudios Clínicos | Segunda Región | |
| China | The sixth People's Hospital of Hebei Province | Baoding | |
| China | Beijing Anding Hospital | Beijing | |
| China | Beijing HuiLongGuan Hospital | Beijing | |
| China | Peking University Sixth Hospital | Beijing | |
| China | Brain hospital of Hunan province | Changsha | |
| China | The Second Xiangya Hospital Of Central South University | Changsha | |
| China | 3rd Affiliated Hosp of Sun yet-sen University | Guangzhou | |
| China | The Affiliated Brain Hospital of Guangzhou Medical University | Guangzhou | |
| China | The Affiliated Hospital of Guizhou Medical University | Guiyang | |
| China | Huzhou Third Municipal Hospital | Huzhou | |
| China | Shandong Daizhuang Hospital | Jining | |
| China | The First Affilliated Hospital Of Kunming of Medical College | Kunming | |
| China | Brain Hospital Affiliated to Nanjing Med University | Nanjing | |
| China | Ningbo Kangning Hospital | Ningbo | |
| China | Shanghai Mental Health Center | Shanghai | |
| China | Tongji Hospital, Tongji University | Shanghai | |
| China | Shenzhen Kangning Hospital | Shenzhen | |
| China | The First Hospital of Hebei Medical University | Shijiazhuang | |
| China | Tianjin Anding Hospital | Tianjin | |
| China | Wuxi mental health center | Wuxi | |
| China | First Affiliated Hospital of Xi'an JiaoTong University | Xi'an | |
| China | Xi'an Mental Health Center | Xi'an | |
| China | The Second Affiliated Hospital of Xinxiang Medical Univ. | Xinxiang | |
| China | Zhumadian Psychiatric Hospital | Zhumadian | |
| Colombia | Centro de Investigación y Proyectos en neurociencia CIPNA | Barranquilla | |
| Colombia | E.S.E Hospital Mental de Antioquia | Bello | |
| Colombia | Instituto Colombiano del Sistema Nervioso- Clínica Montserrat | Bogota | |
| Colombia | Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS | Bogotá | |
| Colombia | Psynapsis Salud Mental S.A. | Pereira | |
| Croatia | Clincal Hospital Centre Rijeka | Rijeka | |
| Croatia | Clinical Hospital Centre Zagreb | Zagreb | |
| Croatia | Psychiatric Hospital 'Sveti Ivan' | Zagreb | |
| Croatia | University Psychiatric Hospital Vrapce | Zagreb | |
| Czechia | National Institute of Mental Health | Klecany | |
| Czechia | EUC Klinika Ostrava, Psychiatrie | Ostrava | |
| Czechia | A-SHINE s.r.o | Plzen | |
| Czechia | INEP medical s.r.o. | Prague | |
| Czechia | PRAGTIS s.r.o. | Prague | |
| Czechia | Psychiatrie Ricany s.r.o. | Ricany | |
| Denmark | Aalborg Universitetsshospital | Aalborg | |
| Denmark | Aarhus University Hospital | Aarhus | |
| Denmark | Psykiatrisk Center Glostrup | Glostrup | |
| Finland | Aurora hospital | Helsinki | |
| Finland | CRST - Clinical Research Services Turku | Turku | |
| France | HOP Charles Perrens | Bordeaux | |
| France | HOP la Colombière | Montpellier | |
| France | HOP Hôtel-Dieu | Nantes | |
| France | HOP Carémeau | Nîmes | |
| France | HOP Rouffach | Rouffach | |
| France | HOP Nord | Saint Priest en Jarez | |
| Germany | Zentrum für klinische Forschung Dr. med. I. Schöll | Bad Homburg | |
| Germany | Praxis Dr. Hahn, Berlin | Berlin | |
| Germany | Studienzentrum für Neurologie und Psychiatrie | Böblingen | |
| Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | |
| Germany | Zentralinstitut für seelische Gesundheit | Mannheim | |
| Germany | Klinikum der Universität München AÖR | München | |
| Germany | Studienzentrum Nord-West | Westerstede | |
| Greece | Eginition Hospital | Athens | |
| Greece | "Attikon" University General Hospital of Attica | Chaidari | |
| Greece | Psychiatric Hospital of Attica | Haidari | |
| Greece | General Oncology Hospital "Agioi Anargyri" | Nea Kifisia | |
| Greece | General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki | |
| Hungary | Semmelweis University | Budapest | |
| Italy | ASST degli Spedali Civili di Brescia | Brescia | |
| Italy | A.O. Fatebenefratelli | Milano | |
| Italy | Ist. San Raffaele Turro | Milano | |
| Italy | Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano (to) | |
| Italy | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | |
| Japan | Hotei Hospital | Aichi, Konan | |
| Japan | Okehazama Hospital Fujita Kokoro Care Center | Aichi, Toyoake | |
| Japan | Toyota Memorial Hospital | Aichi, Toyota | |
| Japan | National Hospital Organization Shimofusa Psychiatric Medical Center | Chiba, Chiba | |
| Japan | National Center for Global Health and Medicine Kohnodai Hospital | Chiba, Ichikawa | |
| Japan | Uematsu Mental Clinic | Fukuoka, Chikugo | |
| Japan | Kuramitsu Hospital | Fukuoka, Fukuoka | |
| Japan | Hirota Clinic | Fukuoka, Kurume | |
| Japan | Kishi Hospital | Gumma, Kiryu | |
| Japan | Obihiro-Kosei General Hospital | Hokkaido, Obihiro | |
| Japan | Hokkaido University Hospital | Hokkaido, Sapporo | |
| Japan | Hokudai-dori Mental Health Clinic | Hokkaido, Sapporo | |
| Japan | Tatsuta Clinic | Hyogo, Kobe | |
| Japan | Kanazawa Medical University Hospital | Ishikwa, Kahoku-gun | |
| Japan | Kishiro Mental Clinic | Kanagawa, Kawasaki | |
| Japan | St. Marianna University Hospital | Kanagawa, Kawasaki | |
| Japan | Hino Hospital | Kanagawa, Yokohama | |
| Japan | Yokohama City University Hospital | Kanagawa, Yokohama | |
| Japan | Yokohama Onoecho Clinic | Kanagawa, Yokohama | |
| Japan | Kochi Health Sciences Center | Kochi, Kochi | |
| Japan | Yuge Neuropsychiatric Hospital | Kumamoto, Kumamoto | |
| Japan | Medical Corporation Yamadakai Yatsushiro Welfare Hospital | Kumamoto, Yatsushiro | |
| Japan | National Hospital Organization Maizuru Medical Center | Kyoto, Maizuru | |
| Japan | Tohoku University Hospital | Miyagi, Sendai | |
| Japan | Shounan Hospital | Nagano, Matsumoto | |
| Japan | Suwa Red Cross Hospital | Nagano, Suwa | |
| Japan | Nara Medical University Hospital | Nara, Kashihara | |
| Japan | Niigata University Medical and Dental Hospital | Niigata, Niigata | |
| Japan | Osaka City Hospital Organization Osaka City General Hospital | Osaka, Osaka | |
| Japan | National Hospital Organization Hizen Psychiatric Medical Center | Saga, Kanzaki-gun | |
| Japan | Rainbow and Sea Hospital | Saga, Karatsu | |
| Japan | Inuo Hospital | Saga, Tosu | |
| Japan | Nishi Kumagaya Hospital | Saitama, Kumagaya | |
| Japan | Tokushima University Hospital | Tokushima, Tokushima | |
| Japan | Medical Corporation Seijin Hospital | Tokyo, Adachi-ku | |
| Japan | Tokyo Medical and Dental University Hospital | Tokyo, Bunkyo-ku | |
| Japan | Nishigahara Hospital | Tokyo, Kita-ku | |
| Japan | National Center of Neurology and Psychiatry | Tokyo, Kodaira | |
| Japan | Asuka Hospital | Tokyo, Machida | |
| Japan | Minami-Aoyama Antique Street Clinic | Tokyo, Minato-ku | |
| Japan | Maynds Tower Mental Clinic | Tokyo, Shibuya-ku | |
| Japan | Shinjuku East Mental Clinic | Tokyo, Shinjuku-ku | |
| Japan | Hokuriku Hospital | Toyama, Nanto | |
| Japan | Yamaguchi University Hospital | Yamaguchi, Ube | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center | Daegu | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Seoul National University Bundang Hospital | Gyeonggi-Do | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | |
| Lithuania | JSC Romuvos Clinic | Kaunas | |
| Lithuania | LUHS KH Psichiatric Clinic Mariu Division | Kaunas | |
| Lithuania | JSC Medical center "Puriena" | Silute | |
| Lithuania | Vilnius City Mental Health Center | Vilnius | |
| Malaysia | Hospital Raja Permaisuri Bainun | Ipoh, Perak | |
| Malaysia | University of Malaya Medical Centre | Kuala Lumpur | |
| Malaysia | Hospital Tuanku Ja'afar | Seremban | |
| Mexico | GabiPros S.C. | Cdmx | |
| Mexico | Centro de Investigación Clinica Acelerada, S.C. | Ciudad de Mexico | |
| Mexico | Instituto Nacional de Neurologia y Neurocirugia | Ciudad de Mexico | |
| Mexico | Clinica Cemelli | Guadalajara | |
| Mexico | Medical Care & Research SA de CV | Merida | |
| Mexico | CIT-Neuropsique S.C | Monterrey | |
| Mexico | Iecsi S.C. | Monterrey | |
| Mexico | Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME). | Monterrey | |
| Mexico | Hospital Universitario Dr Jose Eleuterio Gonzalez | Nuevo León | |
| Mexico | BIND Investigaciones S.C. | San Luis Potosi | |
| New Zealand | North Shore Hospital, Takapuna | Takpuna Auckland | |
| Norway | Sykehuset Østfold HF, avd. Moss | Moss | |
| Norway | Akershus universitetssykehus Oslo | Oslo | |
| Poland | Podlassian Center of Psychogeriatry, Bialystok | Bialystok | |
| Poland | Health Center Alcea | Gdansk | |
| Poland | Central Teaching Hospital of the Medical University of Lodz | Lodz | |
| Poland | Individual Specialist Medical Practice Filip Rybakowski | Poznan | |
| Poland | EUROMEDIS Sp. z o.o., Szczecin | Szczecin | |
| Poland | Institute of Psychiatry and Neurology in Warsaw | Warsaw | |
| Poland | Clinhouse | Zabrze | |
| Romania | Mental Health Center Sector 4 | Bucharest | |
| Romania | SC Carpe Diem SRL | Sibiu | |
| Serbia | Clinical Hospital Center Dr. Dragisa Misovic | Belgrade | |
| Serbia | General Hospital Euromedik | Belgrade | |
| Serbia | Institute for Mental Health | Belgrade | |
| Serbia | Special Hospital for Psychiatric Diseases Gornja Toponica | Gornja Toponica | |
| Serbia | Special Hospital for Psychiatric Diseases Sveti Vracevi | Novi Knezevac | |
| Slovakia | EPAMED s.r.o. | Kosice | |
| Slovakia | Psychiatricka Ambulancia Psycholine s.r.o. | Rimavska Sobota | |
| Spain | Hestia Palau | Barcelona | |
| Spain | Hospital Puerta de Hierro | Majadahonda | |
| Spain | Centro de Salud de San Juan | Salamanca | |
| Spain | Hospital Virgen del Rocío | Sevilla | |
| Spain | Hospital Clínico de Valencia | Valencia | |
| Spain | Hospital Provincial. Complejo Asistencial de Zamora | Zamora | |
| Sweden | Psykiatriska Kliniken | Helsingborg | |
| Sweden | Akademiska sjukhuset | Uppsala | |
| Taiwan | Kai-Syuan Psychiatric Hospital | Kaohsiung | |
| Taiwan | Chang Gung Memorial Hospital Keelung | Keelung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung | |
| Taiwan | NCKUH | Tainan | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Taiwan | Chang Gung Memorial Hospital(Linkou) | Taoyuan | |
| Taiwan | Taoyuan Psychiatric Center | Taoyuan | |
| United Kingdom | Bodmin Community Hospital | Bodmin | |
| United Kingdom | Western General Hospital | Edinburgh | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Warneford Hospital | Oxford | |
| United Kingdom | Moorgreen Hospital | Southampton | |
| United States | Advanced Research Center, Inc. | Anaheim | California |
| United States | Synexus Clinical Research | Atlanta | Georgia |
| United States | Community Clinical Research, Inc. | Austin | Texas |
| United States | Insight Clinical Trials | Beachwood | Ohio |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Clinical Innovations, Inc | Bellflower | California |
| United States | Hassman Research Institute | Berlin | New Jersey |
| United States | Neurobehavioral Research, Inc. | Cedarhurst | New York |
| United States | American Medical Research | Chicago | Illinois |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | ATP Clinical Research, Inc. | Costa Mesa | California |
| United States | Relaro Medical Trials, LLC | Dallas | Texas |
| United States | Midwest Clinical Research | Dayton | Ohio |
| United States | InSite Clinical Research | DeSoto | Texas |
| United States | University of Oregon Prevention Science Institute | Eugene | Oregon |
| United States | JPS Center for Behavioral Health Recovery | Fort Worth | Texas |
| United States | North Texas Clinical Trials | Fort Worth | Texas |
| United States | Center for Behavioral Health, LLC | Gaithersburg | Maryland |
| United States | Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California |
| United States | Institute of Living | Hartford | Connecticut |
| United States | Advanced Medical Research Group Inc | Hollywood | Florida |
| United States | Ben Taub General Hospital | Houston | Texas |
| United States | Omega Clinical Trials,LLC | La Habra | California |
| United States | ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California |
| United States | University of California Los Angeles | Los Angeles | California |
| United States | CCM Clinical Research Group, LLC | Miami | Florida |
| United States | Optimus U Corporation | Miami | Florida |
| United States | San Marcus Research Clinic, Inc. | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Connecticut Mental Health Center | New Haven | Connecticut |
| United States | New York State Psychiatric Institute | New York | New York |
| United States | SP Research, PLLC | Oklahoma City | Oklahoma |
| United States | NRC Research Institute | Orange | California |
| United States | Nova Psychiatry Inc. | Orlando | Florida |
| United States | CNRI - Los Angeles | Pico Rivera | California |
| United States | UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center | Raleigh | North Carolina |
| United States | Arch Clinical Trials, LLC | Saint Louis | Missouri |
| United States | PsychCare Consultants Research | Saint Louis | Missouri |
| United States | Artemis Institute for Clinical Research, LLC | San Diego | California |
| United States | Velocity Clinical Research | Santa Ana | California |
| United States | Richmond Behavioral Associates | Staten Island | New York |
| United States | Collaborative Neuroscience Research | Torrance | California |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, Mexico, New Zealand, Norway, Poland, Romania, Serbia, Slovakia, Spain, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of treatment emergent adverse events (TEAEs) | up to 1 year and 12 days | ||
| Secondary | Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT) | The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S is rated ordinal from 1 to 7, with 1=normal (not at all ill) to 7=patient among the most extremely ill patients. | up to 1 year | |
| Secondary | Change from baseline in Haemoglobin (Hb) to EOT | up to 1 year |
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