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Study identifier: NCT05211947 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Terminated

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

Condition: Schizophrenia  ·  Sponsor: Boehringer Ingelheim

PhasePhase 3
Planned participants1356
Who can joinAll sexes, 18 Years to 51 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where303 locations · 40 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (303)

Advanced Research Center, Inc.Anaheim, California, United States
Clinical Innovations, IncBellflower, California, United States
ProScience Research GroupCulver City, California, United States
Collaborative Neuroscience Network, LLC (CNS)Garden Grove, California, United States
Omega Clinical Trials,LLCLa Habra, California, United States
ASCLEPES Research Centers, P.C. dba Alliance ResearchLong Beach, California, United States
University of California Los AngelesLos Angeles, California, United States
ATP Clinical Research, Inc.Orange, California, United States
NRC Research InstituteOrange, California, United States
CNRI - Los AngelesPico Rivera, California, United States
Artemis Institute for Clinical Research, LLCSan Diego, California, United States
Velocity Clinical Research, Santa AnaSanta Ana, California, United States

+ 291 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

AnaheimBellflowerCulver CityGarden Grove

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