A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
NCT05211947
Phase
Phase 3
Recruitment status
Terminated
Participants
1,356
Lead sponsor
Boehringer Ingelheim
Start date
2022-03-21
Number of sites
- 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.
- Short title
- A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2025-03-18
- First posted
- 2022-01-27
- Registry last updated
- 2026-04-08
- Primary completion date
- 2025-02-26
- Start date
- 2022-03-21
- Actual participants
- 1,356
- Participants
- 1,356
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Boehringer Ingelheim
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05211947
- ClinicalTrials.gov ID
- NCT05211947
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Occurence of Treatment Emergent Adverse Events (TEAEs)
Timeframe: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Number of participants with treatment emergent adverse events.
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks.
The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \[CGI-S EOT\] - \[CGI-S baseline\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 51 Years
- Healthy volunteers
- No
- 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.
Sources for eligibility
- Advanced Research Center, Inc.Anaheim, United States
- Clinical Innovations, IncBellflower, United States
- ProScience Research GroupCulver City, United States
- Collaborative Neuroscience Network, LLC (CNS)Garden Grove, United States
- Omega Clinical Trials,LLCLa Habra, United States
- ASCLEPES Research Centers, P.C. dba Alliance ResearchLong Beach, United States
- University of California Los AngelesLos Angeles, United States
- ATP Clinical Research, Inc.Orange, United States
- NRC Research InstituteOrange, United States
- CNRI - Los AngelesPico Rivera, United States
- Artemis Institute for Clinical Research, LLCSan Diego, United States
- Velocity Clinical Research, Santa AnaSanta Ana, United States
- Stanford University Medical CenterStanford, United States
- Collaborative Neuroscience ResearchTorrance, United States
- Institute of LivingHartford, United States
- Connecticut Mental Health CenterNew Haven, United States
- Advanced Medical Research Group IncHollywood, United States
- Accel Research Sites NetworkMaitland, United States
- San Marcus Research Clinic, Inc.Miami, United States
- CCM Clinical Research Group, LLC-Miami-68482Miami, United States
- Optimus U Corporation-Miami-69452Miami, United States
- University of MiamiMiami, United States
- Nova Psychiatry Inc.Orlando, United States
- Synexus Clinical Research-Atlanta-67262Atlanta, United States
- American Medical ResearchChicago, United States
And 278 more, listed on the interactive page.
Sources for sites
- Related resource (www.clinicalstudies.boehringer-ingelheim.com)
Other registry identifiers
- 2020-003745-11
Sources for references
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Schizophrenia Primary condition