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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05211947
Other study ID # 1346-0014
Secondary ID 2020-003745-11
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 3, 2022
Est. completion date February 24, 2026

Study information

Verified date March 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Iclepertin
Iclepertin

Locations

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
Belgium Universitair Psychiatrisch Centrum Duffel (UPC Duffel) Duffel
Brazil CPN - Centro de Estudos em Neurociências Belo Horizonte
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 Klinikum der Universität München - Campus Innenstadt München
Germany Studienzentrum Nord-West Westerstede
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
Italy ASST degli Spedali Civili di Brescia Brescia
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 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 Saitama Medical University Hospital Saitama, Iruma-gun
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 Showa University Karasuyama Hospital Tokyo, Setagaya
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 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 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 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
Norway Sykehuset Østfold HF, avd. Moss Moss
Norway Akershus universitetssykehus Oslo Oslo
Poland Podlassian Center of Psychogeriatry, Bialystok Bialystok
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
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 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 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 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 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 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 Connecticut Mental Health Center New Haven Connecticut
United States New York State Psychiatric Institute New York New York
United States NRC Research Institute Orange California
United States Nova Psychiatry Inc. Orlando Florida
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 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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Norway,  Poland,  Romania,  Serbia,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

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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