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

a study on Schizophrenia

Summary

Eligibility
for people ages 18-51 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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)

Keywords

Schizophrenia, BI 425809

Eligibility

You can join if…

Open to people ages 18-51

  • 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 CAN'T join 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.

Locations

  • University of California Los Angeles in progress, not accepting new patients
    Los Angeles California 90095 United States
  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • ProScience Research Group in progress, not accepting new patients
    Culver City California 90230 United States
  • Collaborative Neuroscience Research completed
    Torrance California 90504 United States
  • CNRI - Los Angeles in progress, not accepting new patients
    Pico Rivera California 90660 United States
  • Clinical Innovations, Inc completed
    Bellflower California 90706 United States
  • ASCLEPES Research Centers, P.C. dba Alliance Research in progress, not accepting new patients
    Long Beach California 90807 United States
  • Omega Clinical Trials,LLC in progress, not accepting new patients
    La Habra California 90631 United States
  • Collaborative Neuroscience Network, LLC (CNS) accepting new patients
    Garden Grove California 92845 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
Links
Related Info Sign up for this study
ID
NCT05211947
Phase
Phase 3 Schizophrenia Research Study
Study Type
Interventional
Participants
Expecting 1401 study participants
Last Updated
Contact us about this trial