Phase 3
Completed N=201
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Source: ClinicalTrials.gov NCT04186403 ↗Enrolled (actual)
201
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity — 30; 56; 14; 37 Participants
◆ Published Evidence
Emerging
2citations · ~1 / year
A randomised study and an extension study of brexpiprazole in patients with borderline personality disorder.
Summary
This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.
Linked Publications
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A randomised study and an extension study of brexpiprazole in patients with borderline personality disorder.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.