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BI 1358894 for 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.
Awards & highlights

Study Summary

This trial is testing a new medication to see if it can help adults with borderline personality disorder. There are different groups taking different doses of the medication or a placebo, and they are monitored for changes in 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
Secondary outcome measures
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
32%
Headache
9%
Nasopharyngitis
9%
Fatigue
8%
Increased appetite
8%
Dizziness
7%
Influenza
7%
COVID-19
7%
Nausea
6%
Insomnia
6%
Suicidal ideation
5%
Weight increased
4%
Oropharyngeal pain
4%
Dysmenorrhoea
4%
Somnolence
4%
Diarrhoea
3%
Intentional self-injury
3%
Anxiety
2%
Cough
1%
Death
1%
Depression
1%
Suicide attempt
1%
Myocardial infarction
1%
Drug abuse
1%
Oesophageal varices haemorrhage
1%
Abortion spontaneous
1%
Calculus urinary
1%
Jaundice cholestatic
1%
Anaphylactic reaction
1%
Urticaria
1%
Cholelithiasis
1%
Panic attack
1%
Pyrexia
1%
Aggression
1%
Suicidal behaviour
1%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 1358894 125mg
BI 1358894 5mg
BI 1358894 25mg
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
~1160

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,902 Total Patients Enrolled
1 Trials studying Borderline Personality Disorder
48 Patients Enrolled for Borderline Personality Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is most likely to be chosen as a participant for this research?

"This clinical trial requires 390 participants, aged between 18 and 65, who have been diagnosed with Borderline personality disorder (BPD). These individuals must also meet additional criteria such as confirmation of their BPD diagnosis via the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5 PD), a score of 9 or higher on the Zanarini Rating Scale for BPD at screening and randomization visits, male or female gender identity with WOCBP being able to use highly effective contraception methods plus one barrier method, ICH GCP compliant written informed consent prior to admittance into the study."

Answered by AI

How many research centers are overseeing this experiment?

"Currently, 17 clinical trial sites are recruiting patients for this experiment. Places such as Wichita Falls, Cedarhurst and Gainesville are among those featured on the list of locations; selecting a close one may be prudent to reduce travel requirements if you opt in."

Answered by AI

Are individuals over 50 eligible for this research study?

"As per the enrollment conditions, this clinical experiment is open to persons aged 18 and above up until 65 years old."

Answered by AI

Are there currently any openings in this experiment?

"Per the data on clinicaltrials.gov, this particular medical investigation is not currently recruiting patients. It was initially published on November 13th 2020 and its content was last updated a month later in December 2020. Nevertheless, there are 60 other studies actively enrolling participants at present time"

Answered by AI

What potential adverse reactions are associated with BI 1358894?

"As this is a Phase 2 trial, and only limited data exists to confirm its safety, BI 1358894 earned a rating of 2 on our team's risk-assessment scale."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
California
New Jersey
Other
How old are they?
18 - 65
What site did they apply to?
McLean Hospital
Core Clinical Research
Center For Emotional Fitness
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Advanced Research Center, Inc.: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
2020. "A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04566601.
~88 spots leftby Apr 2025
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