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NCT04602221 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04602221: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT04602221 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04602221, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.
Primary Outcome
Paired Associate Learning (PAL) assesses visual memory and new learning. Boxes are displayed on the screen and open in turn to reveal a number of patterns. Participants are instructed to try to remember the location in which each pattern was shown. After all the boxes have been opened, each pattern is then shown in the center of the screen in a randomised order, and the participant touches the box in which the pattern was located. If an error is made, all the patterns are re-presented to remind
Interventions
- DRUG Placebo
- DRUG Lamotrigine
- DRUG BI 409306
- DRUG BI 425809
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 1 |
What the finished NCT04602221 record still lists
NCT04602221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04602221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04602221 about?
NCT04602221 is a clinical study titled "A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine". The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.
What is the current status of trial NCT04602221?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-12-01. Estimated completion is 2022-08-12.
What interventions are being tested in trial NCT04602221?
The interventions under investigation include: Placebo (DRUG), Lamotrigine (DRUG), BI 409306 (DRUG), BI 425809 (DRUG).
Who is sponsoring clinical trial NCT04602221?
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 NCT04602221's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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