A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study

April 15, 2024 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1401

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Banfield, Argentina, B1228CKR
      • Caba, Argentina, 1058AAJ
        • Recruiting
        • CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)
        • Contact:
      • Caba, Argentina, C1405BOA
        • Recruiting
        • Fundación FunDaMos para la asistencia e investigación en psiquiatría
        • Contact:
      • Caba, Argentina, C1133AAH
        • Recruiting
        • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
        • Contact:
      • Cordoba, Argentina, 5004
        • Recruiting
        • CEN (Centro Especializado Neurociencias)
        • Contact:
      • Cordoba, Argentina, X5003DCE
      • Córdoba, Argentina, X5009
      • Córdoba, Argentina, X5000FAL
        • Recruiting
        • Instituto Modelo de Neurología Lennox
        • Contact:
      • La Plata, Argentina, 1900
        • Recruiting
        • Clinica Privada de Salud Mental Santa Teresa de Avila
        • Contact:
      • La Plata, Argentina, 1900
        • Recruiting
        • Instituto de Neurociencias San Agustín
        • Contact:
      • Mendoza, Argentina, 5502
        • Recruiting
        • Resolution Psychopharmacology Research Institute
        • Contact:
      • Rosario, Argentina, S2000QJI
        • Recruiting
        • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
        • Contact:
      • Rosario, Argentina, 2000
        • Recruiting
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Contact:
      • San Vicente, Argentina, X5006CBI
  • Belgium
      • Duffel, Belgium, 2570
        • Recruiting
        • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
        • Contact:
  • Brazil
      • Belo Horizonte, Brazil, 30150-270
        • Recruiting
        • CPN - Centro de Estudos em Neurociências
        • Contact:
      • Criciuma, Brazil, 88811-000
      • Curitiba, Brazil, 80.240-280
        • Recruiting
        • Trial Tech- Tecnologia em pesquisa com medicamentos
        • Contact:
      • Goiania, Brazil, 74093-040
        • Recruiting
        • J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria
        • Contact:
      • Rio de Janeiro, Brazil, 22270-060
        • Recruiting
        • Ruschel Medicina e Pesquisa Clínica
        • Contact:
      • Sao Jose do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Hospital de Base - Fac Med de Sao Jose do Rio Preto
        • Contact:
      • Sao Paulo, Brazil, 04020-060
        • Recruiting
        • Clínica Viver - Centro de Desospitalização Humana
        • Contact:
      • Sao Paulo, Brazil, 01236-030
      • São Bernardo do Campo, Brazil, 09780-000
        • Recruiting
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
        • Contact:
      • São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica Ltda
        • Contact:
      • São Paulo, Brazil, 05403-903
        • Recruiting
        • Hospital das Clinicas da FMUSP
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
  • Chile
      • Santiago, Chile, 7500710
        • Recruiting
        • BioMedica Research Group
        • Contact:
      • Segunda Región, Chile, 1270244
        • Recruiting
        • Psicomed Estudios Clínicos
        • Contact:
  • China
      • Baoding, China, 71000
        • Recruiting
        • The sixth People's Hospital of Hebei Province
        • Contact:
      • Beijing, China, 100089
        • Recruiting
        • Peking University Sixth Hospital
        • Contact:
      • Beijing, China, 100096
        • Recruiting
        • Beijing HuiLongGuan Hospital
        • Contact:
      • Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital
        • Contact:
      • Changsha, China, 410007
        • Recruiting
        • Brain Hospital of Hunan Province
        • Contact:
      • Changsha, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Guangzhou, China, 510370
        • Recruiting
        • The Affiliated Brain Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, China, 510630
        • Recruiting
        • 3rd Affiliated Hosp of Sun yet-sen University
        • Contact:
      • Guiyang, China, 550000
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Third Municipal Hospital
        • Contact:
      • Jining, China, 272051
        • Recruiting
        • Shandong Daizhuang Hospital
        • Contact:
      • Kunming, China, 650032
        • Recruiting
        • The First Affilliated Hospital Of Kunming of Medical College
        • Contact:
      • Nanjing, China, 210029
        • Recruiting
        • Brain Hospital Affiliated to Nanjing Med University
        • Contact:
      • Ningbo, China, 315201
        • Recruiting
        • NingBo KangNing Hospital
        • Contact:
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
      • Shanghai, China, 200065
        • Recruiting
        • Tongji Hospital, Tongji University
        • Contact:
      • Shenzhen, China, 518003
        • Recruiting
        • Shenzhen Kangning Hospital
        • Contact:
      • Shijiazhuang, China, 050030
        • Recruiting
        • The First Hospital Of Hebei Medical University
        • Contact:
      • Tianjin, China, 300222
        • Recruiting
        • Tianjin Anding Hospital
        • Contact:
      • Wuxi, China, 214151
        • Recruiting
        • Wuxi mental health center
        • Contact:
      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, China, 710101
        • Recruiting
        • Xi'an Mental Health Center
        • Contact:
      • Xinxiang, China, 453002
        • Recruiting
        • The Second Affiliated Hospital of Xinxiang Medical Univ.
        • Contact:
      • Zhumadian, China, 463000
        • Recruiting
        • Zhumadian Psychiatric Hospital
        • Contact:
  • Colombia
      • Barranquilla, Colombia, 80020
        • Recruiting
        • Centro de Investigación y Proyectos en neurociencia CIPNA
        • Contact:
      • Bello, Colombia, 51053
        • Recruiting
        • E.S.E Hospital Mental de Antioquia
        • Contact:
      • Bogota, Colombia, 110121
        • Recruiting
        • Instituto Colombiano del Sistema Nervioso- Clínica Montserrat
        • Contact:
      • Bogotá, Colombia, 111166
        • Recruiting
        • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS
        • Contact:
      • Pereira, Colombia, 660003
  • Croatia
      • Rijeka, Croatia, 51 000
      • Zagreb, Croatia, 10090
      • Zagreb, Croatia, 10090
        • Recruiting
        • University Psychiatric Hospital Vrapce
        • Contact:
      • Zagreb, Croatia, 10 000
  • Czechia
      • Klecany, Czechia, 25067
        • Recruiting
        • National Institute of Mental Health
        • Contact:
      • Ostrava, Czechia, 70800
        • Recruiting
        • EUC Klinika Ostrava, Psychiatrie
        • Contact:
      • Plzen, Czechia, 30100
      • Prague, Czechia, 18600
      • Prague, Czechia, 120 00
      • Ricany, Czechia, 251 01
        • Recruiting
        • Psychiatrie Ricany s.r.o.
        • Contact:
  • Denmark
      • Aalborg, Denmark, 9000
      • Aarhus, Denmark, 8200
      • Glostrup, Denmark, 2600
  • Finland
      • Helsinki, Finland, 00250
      • Turku, Finland, 20520
        • Recruiting
        • CRST - Clinical Research Services Turku
        • Contact:
  • France
      • Bordeaux, France, 33076
      • Montpellier, France, 34295
      • Nantes, France, 44093
      • Nîmes, France, 30029
      • Rouffach, France, 68250
      • Saint Priest en Jarez, France, 42270
  • Germany
      • Bad Homburg, Germany, 61350
        • Recruiting
        • Zentrum für klinische Forschung Dr. med. I. Schöll
        • Contact:
      • Berlin, Germany, 13187
      • Böblingen, Germany, 71034
        • Recruiting
        • Studienzentrum fur Neurologie und Psychiatrie
        • Contact:
      • München, Germany, 80336
      • Westerstede, Germany, 26655
  • Greece
      • Chaidari, Greece, 12462
        • Recruiting
        • "Attikon" University General Hospital of Attica
        • Contact:
      • Haidari, Greece, 12462
        • Recruiting
        • Psychiatric Hospital of Attica
        • Contact:
      • Nea Kifisia, Greece, 14564
        • Recruiting
        • General Oncology Hospital "Agioi Anargyri"
        • Contact:
      • Thessaloniki, Greece, 57 010
        • Recruiting
        • General Hospital of Thessaloniki "G. Papanikolaou"
        • Contact:
  • Italy
      • Brescia, Italy, 25123
        • Active, not recruiting
        • ASST degli Spedali Civili di Brescia
      • Milano, Italy, 20121
      • Milano, Italy, 20127
        • Active, not recruiting
        • Ist. San Raffaele Turro
      • Orbassano (to), Italy, 10043
        • Completed
        • Azienda Sanitaria Ospedale S. Luigi Gonzaga
      • Siena, Italy, 53100
        • Recruiting
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
        • Contact:
  • Japan
      • Aichi, Konan, Japan, 483-8248
      • Aichi, Toyoake, Japan, 470-1168
        • Recruiting
        • Okehazama Hospital Fujita Kokoro Care Center
        • Contact:
      • Aichi, Toyota, Japan, 471-8513
        • Recruiting
        • Toyota Memorial Hospital
        • Contact:
      • Chiba, Chiba, Japan, 266-0007
        • Recruiting
        • National Hospital Organization Shimofusa Psychiatric Medical Center
        • Contact:
      • Chiba, Ichikawa, Japan, 272-8516
        • Recruiting
        • National Center for Global Health and Medicine Kohnodai Hospital
        • Contact:
      • Fukuoka, Chikugo, Japan, 833-0041
      • Fukuoka, Fukuoka, Japan, 819-0037
      • Fukuoka, Kurume, Japan, 830-0033
      • Gumma, Kiryu, Japan, 376-0011
      • Hokkaido, Obihiro, Japan, 080-0024
        • Recruiting
        • Obihiro-Kosei General Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
      • Hokkaido, Sapporo, Japan, 001-0010
        • Recruiting
        • Hokudai-dori Mental Health Clinic
        • Contact:
      • Hyogo, Kobe, Japan, 651-0097
      • Ishikwa, Kahoku-gun, Japan, 920-0293
        • Recruiting
        • Kanazawa Medical University Hospital
        • Contact:
      • Kanagawa, Kawasaki, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital
        • Contact:
      • Kanagawa, Kawasaki, Japan, 214-0014
      • Kanagawa, Yokohama, Japan, 231-0015
      • Kanagawa, Yokohama, Japan, 234-0051
      • Kanagawa, Yokohama, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
      • Kochi, Kochi, Japan, 781-8555
        • Recruiting
        • Kochi Health Sciences Center
        • Contact:
      • Kumamoto, Kumamoto, Japan, 861-8002
        • Recruiting
        • Yuge Neuropsychiatric Hospital
        • Contact:
      • Kumamoto, Yatsushiro, Japan, 866-0043
        • Recruiting
        • Medical Corporation Yamadakai Yatsushiro Welfare Hospital
        • Contact:
      • Kyoto, Maizuru, Japan, 625-8502
        • Recruiting
        • National Hospital Organization Maizuru Medical Center
        • Contact:
      • Miyagi, Sendai, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
        • Contact:
      • Nagano, Matsumoto, Japan, 390-0847
      • Nagano, Suwa, Japan, 392-8510
      • Nara, Kashihara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital
        • Contact:
      • Niigata, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical and Dental Hospital
        • Contact:
      • Osaka, Osaka, Japan, 534-0021
        • Recruiting
        • Osaka City Hospital Organization Osaka City General Hospital
        • Contact:
      • Saga, Kanzaki-gun, Japan, 842-0192
        • Recruiting
        • National Hospital Organization Hizen Psychiatric Medical Center
        • Contact:
      • Saga, Karatsu, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
      • Saga, Tosu, Japan, 841-0081
      • Saitama, Iruma-gun, Japan, 350-0495
        • Recruiting
        • Saitama Medical University Hospital
        • Contact:
      • Saitama, Kumagaya, Japan, 360-0816
      • Tokushima, Tokushima, Japan, 770-8503
        • Recruiting
        • Tokushima University Hospital
        • Contact:
      • Tokyo, Adachi-ku, Japan, 121-8515
        • Recruiting
        • Medical Corporation Seijin Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Recruiting
        • Tokyo Medical and Dental University Hospital
        • Contact:
      • Tokyo, Kita-ku, Japan, 114-0024
      • Tokyo, Kodaira, Japan, 187-8851
        • Recruiting
        • National Center of Neurology and Psychiatry
        • Contact:
      • Tokyo, Machida, Japan, 194-0005
      • Tokyo, Minato-ku, Japan, 107-0062
        • Recruiting
        • Minami-Aoyama Antique Street Clinic
        • Contact:
      • Tokyo, Setagaya, Japan, 157-8577
        • Recruiting
        • Showa University Karasuyama Hospital
        • Contact:
      • Tokyo, Shibuya-ku, Japan, 151-0053
        • Recruiting
        • Maynds Tower Mental Clinic
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-0022
        • Recruiting
        • Shinjuku East Mental Clinic
        • Contact:
      • Toyama, Nanto, Japan, 939-1893
      • Yamaguchi, Ube, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
      • Daegu, Korea, Republic of, 42472
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
      • Gyeonggi-Do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Yangsan, Korea, Republic of, 626-770
        • Completed
        • Pusan National University Yangsan Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-44279
      • Silute, Lithuania, LT-99142
        • Completed
        • JSC Medical center "Puriena"
      • Vilnius, Lithuania, LT-10309
  • Malaysia
      • Ipoh, Perak, Malaysia, 30450
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University of Malaya Medical Centre
        • Contact:
      • Seremban, Malaysia, 70300
  • Mexico
      • Cdmx, Mexico, 07810
      • Ciudad de Mexico, Mexico, 14269
        • Recruiting
        • Instituto Nacional de Neurologia y Neurocirugia
        • Contact:
      • Ciudad de Mexico, Mexico, 07369
        • Recruiting
        • Centro de Investigación Clinica Acelerada, S.C.
        • Contact:
      • Guadalajara, Mexico, 44660
      • Merida, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
        • Contact:
      • Monterrey, Mexico, 64610
      • Monterrey, Mexico, 64710
        • Recruiting
        • Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).
        • Contact:
      • Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
        • Contact:
      • San Luis Potosi, Mexico, 78213
        • Recruiting
        • BIND Investigaciones S.C.
        • Contact:
  • Norway
      • Moss, Norway, N-1535
        • Recruiting
        • Sykehuset Østfold HF, avd. Moss
        • Contact:
      • Oslo, Norway, 0963
        • Recruiting
        • Akershus universitetssykehus Oslo
        • Contact:
  • Poland
      • Bialystok, Poland, 15-756
        • Recruiting
        • Podlassian Center of Psychogeriatry, Bialystok
        • Contact:
      • Lodz, Poland, 92-216
        • Recruiting
        • Central Teaching Hospital of the Medical University of Lodz
        • Contact:
      • Poznan, Poland, 60-744
        • Recruiting
        • Individual Specialist Medical Practice Filip Rybakowski
        • Contact:
      • Szczecin, Poland, 70-111
        • Recruiting
        • EUROMEDIS Sp. z o.o., Szczecin
        • Contact:
      • Warsaw, Poland, 02-957
        • Recruiting
        • Institute of Psychiatry and Neurology in Warsaw
        • Contact:
      • Zabrze, Poland, 41-807
  • Romania
      • Bucharest, Romania, 040872
        • Recruiting
        • Mental Health Center Sector 4
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • General Hospital Euromedik
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute for Mental Health
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Dr. Dragisa Misovic
        • Contact:
      • Novi Knezevac, Serbia, 23330
        • Recruiting
        • Special Hospital for Psychiatric Diseases Sveti Vračevi
        • Contact:
  • Slovakia
      • Kosice, Slovakia, 040 01
      • Rimavska Sobota, Slovakia, 97901
        • Recruiting
        • Psychiatricka Ambulancia Psycholine s.r.o.
        • Contact:
  • Spain
      • Barcelona, Spain, 08025
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
      • Salamanca, Spain, 37005
        • Recruiting
        • Centro de Salud de San Juan
        • Contact:
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocio
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
      • Zamora, Spain, 49021
        • Recruiting
        • Hospital Provincial. Complejo Asistencial de Zamora
        • Contact:
  • Sweden
      • Helsingborg, Sweden, 201 53
      • Uppsala, Sweden, 751 85
  • Taiwan
      • Kaohsiung, Taiwan, 802
        • Recruiting
        • Kai-Syuan Psychiatric Hospital
        • Contact:
      • Taichung, Taiwan, 40201
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taoyuan, Taiwan, 330
        • Recruiting
        • Chang Gung Memorial Hospital(Linkou)
        • Contact:
      • Taoyuan, Taiwan, 33058
        • Recruiting
        • Taoyuan Psychiatric Center
        • Contact:
  • United Kingdom
      • Bodmin, United Kingdom, PL31 2QT
      • Glasgow, United Kingdom, G51 4TF
      • Oxford, United Kingdom, OX3 7JX
      • Southampton, United Kingdom, SO30 3JB
  • United States
    • California
      • Anaheim, California, United States, 92805
      • Bellflower, California, United States, 90706
      • Costa Mesa, California, United States, 92626
      • Garden Grove, California, United States, 92845
      • La Habra, California, United States, 90631
      • Long Beach, California, United States, 90807
        • Recruiting
        • ASCLEPES Research Centers, P.C. dba Alliance Research
        • Contact:
      • Los Angeles, California, United States, 90095
      • Orange, California, United States, 92868
      • San Diego, California, United States, 92103
      • Santa Ana, California, United States, 92704
      • Torrance, California, United States, 90504
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • Florida
      • Hollywood, Florida, United States, 33021
      • Miami, Florida, United States, 33014
      • Miami, Florida, United States, 33133
      • Miami, Florida, United States, 33135
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30328
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • New York
      • Cedarhurst, New York, United States, 11516
      • New York, New York, United States, 10032
      • Staten Island, New York, United States, 10314
    • North Carolina
      • Raleigh, North Carolina, United States, 27608
        • Recruiting
        • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
        • Contact:
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Cincinnati, Ohio, United States, 45219
      • Dayton, Ohio, United States, 45417
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Texas
      • Austin, Texas, United States, 78754
      • Dallas, Texas, United States, 75243
      • DeSoto, Texas, United States, 75115
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
    • Washington
      • Bellevue, Washington, United States, 98007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with cognitive impairment due to schizophrenia
Drug: Iclepertin
Iclepertin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of treatment emergent adverse events (TEAEs)
Time Frame: up to 1 year and 12 days
up to 1 year and 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT)
Time Frame: up to 1 year
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
Change from baseline in Haemoglobin (Hb) to EOT
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Estimated)

February 6, 2026

Study Completion (Estimated)

February 24, 2026

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1346-0014
  • 2020-003745-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.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.

IPD Sharing Time Frame

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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