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A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in ders-16 total score at week 10 was calculated using the mmrm model which is a longitudinal analyses and it incorporates ders-16 measurements from baseline, weeks 1, 2, 4, 6, 8 and week 10.

Summary

This trial is testing a new medicine called BI 1358894 to see if it helps adults with borderline personality disorder. Participants take different doses of the medicine for several months. The study compares the effects of the medicine to check if it reduces symptoms.

Eligible Conditions
  • Borderline Personality Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in ders-16 total score at week 10 was calculated using the mmrm model which is a longitudinal analyses and it incorporates ders-16 measurements from baseline, weeks 1, 2, 4, 6, 8 and week 10.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in ders-16 total score at week 10 was calculated using the mmrm model which is a longitudinal analyses and it incorporates ders-16 measurements from baseline, weeks 1, 2, 4, 6, 8 and week 10. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
Secondary study objectives
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10
Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10
Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10
+3 more

Side effects data

From 2023 Phase 2 trial • 390 Patients • NCT04566601
35%
Headache
12%
Anxiety
12%
Fatigue
12%
Dizziness
10%
Insomnia
10%
Nausea
8%
Diarrhoea
8%
Pyrexia
6%
Nasopharyngitis
6%
Suicidal ideation
6%
COVID-19
6%
Influenza
6%
Disturbance in attention
6%
Oropharyngeal pain
6%
Pharyngitis
6%
Somnolence
4%
Intentional self-injury
4%
Constipation
4%
Dyspepsia
2%
Initial insomnia
2%
Dysmenorrhoea
2%
Suicidal behaviour
2%
Weight increased
2%
Increased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 1358894 5mg
BI 1358894 25mg
BI 1358894 125mg
Placebo
BI 1358894 75mg

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1358894 75mgExperimental Treatment1 Intervention
Group II: BI 1358894 5mgExperimental Treatment1 Intervention
Group III: BI 1358894 25mgExperimental Treatment1 Intervention
Group IV: BI 1358894 125mgExperimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1358894
2020
Completed Phase 2
~1480

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,857,635 Total Patients Enrolled
2 Trials studying Borderline Personality Disorder
68 Patients Enrolled for Borderline Personality Disorder
~77 spots leftby Dec 2025
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