Status:
TERMINATED
A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Schizophrenia
Eligibility:
All Genders
18-51 years
Phase:
PHASE3
Brief 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 schiz...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2025
Estimated Enrollment :
1362 Patients enrolled
Trial Details
Trial ID
NCT05211947
Start Date
March 21 2022
End Date
March 18 2025
Last Update
May 28 2025
Active Locations (303)
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1
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
2
Clinical Innovations, Inc
Bellflower, California, United States, 90706
3
ProScience Research Group
Culver City, California, United States, 90230
4
Collaborative Neuroscience Network, LLC (CNS)
Garden Grove, California, United States, 92845