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NCT04566601 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
NCT04566601: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04566601 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 390 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566601, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
Study Summary
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.
Primary Outcome
The ZAN-BPD scale reflects the nine DSM-5 criteria and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms. Least Squares (LS) mean and standard error were estimated by restricted ma
Interventions
- DRUG Placebo
- DRUG BI 1358894
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2023-01-25 |
| Phase | Phase 2 |
What the finished NCT04566601 record still lists
NCT04566601 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04566601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04566601 about?
NCT04566601 is a clinical study titled "A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder". This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put ...
What is the current status of trial NCT04566601?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2020-11-13. Estimated completion is 2023-01-25.
What interventions are being tested in trial NCT04566601?
The interventions under investigation include: Placebo (DRUG), BI 1358894 (DRUG).
Who is sponsoring clinical trial NCT04566601?
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 NCT04566601's enrollment target sits among peer trials
390 106th of 2000 higher than 1,893 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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