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NCT04846881 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)
A Phase 3 study of Schizophrenia, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 611
- Enrollment target
- 20
- Study locations
NCT04846881: Completed Phase 3 study of Schizophrenia, sponsored by Boehringer Ingelheim.
NCT04846881 is a Phase 3 study of Schizophrenia that has completed, run by Boehringer Ingelheim. The registered enrollment target is 611 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04846881, a Phase 3 study of Schizophrenia, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 611 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.
Primary Outcome
The change from baseline in MCCB (MATRICS Consensus Cognitive Battery) overall composite T-score at Week 26 is reported. This was analyzed using a mixed-effects model for repeated measurements (MMRM) comparing the change from baseline in MCCB overall composite T-score at Week 26 between iclepertin 10 mg daily and placebo. The MCCB comprises 10 tests to measure cognitive performance in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Iclepertin
Study Locations (20)
California
- Clinical Innovations, Inc - Bellflower
- ATP Clinical Research, Inc. - Costa Mesa
- ASCLEPES Research Centers, P.C. dba Alliance Research - Long Beach
- University of California Los Angeles - Los Angeles
- NRC Research Institute - Orange
- Collaborative Neuroscience Research, LLC-Torrance-69527 - Torrance
Florida
- Research in Miami Inc - Hialeah
- Optimus U Corporation-Miami-69452 - Miami
- Health Synergy Clinical Research, LLC - West Palm Beach
New York
- Neurobehavioral Research, Inc. - Cedarhurst
- New York State Psychiatric Institute - New York
Texas
- Relaro Medical Trials, LLC - Dallas
- John Peter Smith Health Network - Fort Worth
Connecticut
- Connecticut Mental Health Center - New Haven
Illinois
- American Medical Research - Chicago
Maryland
- Sheppard Pratt Physicians's Practice Association, Inc. - Baltimore
Missouri
- PsychCare Consultants Research - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-11-17 |
| Phase | Phase 3 |
What the finished NCT04846881 record still lists
NCT04846881 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (182% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04846881 names 20 study sites across 11 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04846881 about?
NCT04846881 is a clinical study titled "Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)". This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or pla...
What is the current status of trial NCT04846881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 611 participants. The study started on 2021-08-24. Estimated completion is 2024-11-17.
What conditions does trial NCT04846881 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT04846881?
The interventions under investigation include: Placebo (DRUG), Iclepertin (DRUG).
Who is sponsoring clinical trial NCT04846881?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04846881 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04846881's enrollment target sits among peer trials
611 26th of 315 higher than 290 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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