A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
Public ClinicalTrials.gov record NCT05211947. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05211947
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,356 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 51 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 21, 2022 (Actual)
- Primary completion
- Feb 26, 2025 (Actual)
- Completion
- Mar 18, 2025 (Actual)
- Last update posted
- Apr 8, 2026
2022 – 2025
United States locations
- U.S. sites
- 49
- U.S. states
- 17
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Clinical Innovations, Inc | Bellflower | California | 90706 | — |
| ProScience Research Group | Culver City | California | 90230 | — |
| Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California | 92845 | — |
| Omega Clinical Trials,LLC | La Habra | California | 90631 | — |
| ASCLEPES Research Centers, P.C. dba Alliance Research | Long Beach | California | 90807 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| ATP Clinical Research, Inc. | Orange | California | 92866 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| CNRI - Los Angeles | Pico Rivera | California | 90660 | — |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | — |
| Velocity Clinical Research, Santa Ana | Santa Ana | California | 92704 | — |
| Stanford University Medical Center | Stanford | California | 94304 | — |
| Collaborative Neuroscience Research | Torrance | California | 90504 | — |
| Institute of Living | Hartford | Connecticut | 06106 | — |
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | — |
| Advanced Medical Research Group Inc | Hollywood | Florida | 33021 | — |
| Accel Research Sites Network | Maitland | Florida | 32751 | — |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33014 | — |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | — |
| Optimus U Corporation-Miami-69452 | Miami | Florida | 33135 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Nova Psychiatry Inc. | Orlando | Florida | 32803 | — |
| Synexus Clinical Research-Atlanta-67262 | Atlanta | Georgia | 30328 | — |
| American Medical Research | Chicago | Illinois | 60612 | — |
| Sheppard Pratt Physicians's Practice Association, Inc. | Baltimore | Maryland | 21204 | — |
| Center for Behavioral Health, LLC | Gaithersburg | Maryland | 20877 | — |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | — |
| Arch Clinical Trials, LLC | St Louis | Missouri | 63141 | — |
| Omaha Insomnia and Psychiatric Services | Omaha | Nebraska | 68144 | — |
| Hassman Research Institute-Marlton-66897 | Marlton | New Jersey | 08053 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| New York State Psychiatric Institute | New York | New York | 10032 | — |
| Richmond Behavioral Associates-Staten Island-68636 | Staten Island | New York | 10314 | — |
| UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center | Raleigh | North Carolina | 27608 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Midwest Clinical Research | Dayton | Ohio | 45417 | — |
| Insight Clinical Trials, LLC, Independence | Independence | Ohio | 44131 | — |
| SP Research, PLLC | Oklahoma City | Oklahoma | 73112 | — |
| University of Oregon Prevention Science Institute | Eugene | Oregon | 97403 | — |
| Oasis Life Care | State College | Pennsylvania | 16801 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| JPS Center for Behavioral Health Recovery | Fort Worth | Texas | 76104 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| Ben Taub General Hospital | Houston | Texas | 77030 | — |
| LinQ Research, LLC-Richmond-70076 | Richmond | Texas | 77407 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 254 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05211947, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05211947 live on ClinicalTrials.gov.