Clinical trial NCT04186403: Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Official title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Borderline Personality Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
timeFrame: Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
Secondary outcomes:
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Screening up to Week 12
measure: Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
timeFrame: Screening up to Week 12
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
timeFrame: Screening up to Week 12
measure: Change From Baseline in Simpson-Angus Scale (SAS) Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
timeFrame: Baseline and Week 12
measure: Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: New York
Study officials:
References: