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

Stopped early · Phase 3

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT05211947

Run by

Boehringer Ingelheim

People needed

1356

Starts

2022-03-21

Expected to finish

2025-03-18

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 51. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Research Center, Inc. — Anaheim, California, United States
• Clinical Innovations, Inc — Bellflower, California, United States
• ProScience Research Group — Culver City, California, United States
• Collaborative Neuroscience Network, LLC (CNS) — Garden Grove, California, 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
• ATP Clinical Research, Inc. — Orange, California, United States
• NRC Research Institute — Orange, California, United States
• CNRI - Los Angeles — Pico Rivera, California, United States
• Artemis Institute for Clinical Research, LLC — San Diego, California, United States
• Velocity Clinical Research, Santa Ana — Santa Ana, California, United States
• Sint-Kamillus — Bierbeek, Belgium
• Stanford University Medical Center — Stanford, California, United States
• Collaborative Neuroscience Research — Torrance, California, United States
• Institute of Living — Hartford, Connecticut, United States
• Connecticut Mental Health Center — New Haven, Connecticut, United States
• Advanced Medical Research Group Inc — Hollywood, Florida, United States
• Accel Research Sites Network — Maitland, Florida, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• CCM Clinical Research Group, LLC-Miami-68482 — Miami, Florida, United States
• Optimus U Corporation-Miami-69452 — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Nova Psychiatry Inc. — Orlando, Florida, United States
• CUP Vivalia -La Clairière — Bertix, Belgium

Full record on ClinicalTrials.gov

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