Phase 3
N=201
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Borderline Personality Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04186403 ↗Enrolled (actual)
201
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity — 30; 56; 14; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity |
30; 56; 14; 37; 19; 30 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities |
3; 1; 7; 4; 9; 26 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities |
1; 0; 13; 11; 22; 19 | — |
| SECONDARY Change From Baseline in Simpson-Angus Scale (SAS) Total Score |
0.2; 0.1; -0.1; 0.0 | — |
| SECONDARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score |
0.0; 0.1; 0.0; -0.1 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score |
0.1; 0.1; -0.1; -0.0 | — |
| SECONDARY Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
28; 28; 0; 2 | — |
Summary
This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.
Eligibility Criteria
Inclusion Criteria
- Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
- Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
Exclusion Criteria
- Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP).
- Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
- Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline.
- Participants who develop a medically significant abnormality.
Data sourced from ClinicalTrials.gov (NCT04186403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.