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NCT04846868 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 620
- Enrollment target
NCT04846868: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT04846868 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 620 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04846868, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 620 participants
- Enrollment target
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 and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
Primary Outcome
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The larger the MCCB overall composite T-score, the better patient cognition. A mean T-score of 50 and a standard deviation of 10 reflects the general population. The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on on-treatment
Interventions
- DRUG Placebo
- DRUG Iclepertin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 3 |
What the finished NCT04846868 record still lists
NCT04846868 is an interventional study that assigns participants to a tested intervention. The registered 620 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04846868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04846868 about?
NCT04846868 is a clinical study titled "Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)". 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 NCT04846868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 620 participants. The study started on 2021-09-08. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT04846868?
The interventions under investigation include: Placebo (DRUG), Iclepertin (DRUG).
Who is sponsoring clinical trial NCT04846868?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04846868's enrollment target sits among peer trials
620 589th of 2000 higher than 1,410 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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