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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 390 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG BI 1358894

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2020-11-13
Est. Completion 2023-01-25
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT04566601

The ClinicalTrials.gov registry entry for NCT04566601 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04566601 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.