Last updated 22 days ago

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

1401 patients around the world

Available in Mexico, United States

Boehringer Ingelheim

1401Patients around the world

Requirements for the patient

To 51 Years

All Gender

: 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.

: 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.

SponsorBoehringer Ingelheim

Study typeInterventional

Requirements

To 51 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05211947