Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder

This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: Brexpiprazole

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10012
      • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prior Brexpiprazole 2-3 Milligrams Per Day; Participants who received blinded brexpiprazole 2 to 3 milligrams per day (mg/day) in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.	Drug: Brexpiprazole; Administered as tablets.; Other Names: OPC-34712; Rexulti
Experimental: Prior Placebo; Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks.	Drug: Brexpiprazole; Administered as tablets.; Other Names: OPC-34712; Rexulti

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity	An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity).	Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities	Potentially clinically significant ECG abnormalities included rate: Bradycardia (vent <=50 beats per minute [bpm] and decrease >=15 bpm); Rhythm: Sinus bradycardia (<=50 bpm and decrease >=15 bpm), absence during baseline and presence of ventricular premature beat post baseline; ST/T morphology: Absence at baseline and presence of symmetrical T-wave inversion post baseline.	Screening up to Week 12
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities	Potentially clinically significant vital sign abnormalities included: Heart rate standing in bpm (<50 bpm and decrease >=15 bpm, >120 bpm and increase >=15 bpm); Weight in kilograms (kgs) (decrease >=7%, increase >=7%).	Screening up to Week 12
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities	Potentially clinically significant laboratory abnormalities included serum chemistry: Prolactin >upper limit of normal (ULN) (nanograms per millilitre [ng/ml] in males and females), fasting glucose ≥100 (milligrams per decilitre [mg/dl]), fasting high-density lipoprotein (HDL) cholesterol <40 (men)/ <50 (women) (mg/dl), fasting low-density lipoprotein (LDL) cholesterol ≥160 (mg/dl), fasting cholesterol ≥240 (mg/dl), fasting triglycerides ≥150 (mg/dl); Creatine phosphokinase (CPK)/renal: Creatine kinase >3xULN (units per litre [U/l]), creatinine ≥2.0 (mg/dl), urea nitrogen ≥30 (mg/dl).	Screening up to Week 12
Change From Baseline in Simpson-Angus Scale (SAS) Total Score	The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.	Baseline and Week 12
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score	The AIMS scale consists of 10 items describing symptoms of dyskinesia: Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) (for item 10, no awareness) to 4 (severe condition) (for item 10, awareness, severe distress). AIMS total score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.	Baseline and Week 12
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score	The BARS consists of 4 items related to akathisia: Objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The fourth item, global clinical evaluation was rated on a 6-point scale, with a score range of 0 (absence of symptoms) to 5 (severe akathisia). Lower scores indicate less symptoms and negative change from baseline indicate less symptoms.	Baseline and Week 12
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior.	Baseline up to Week 12

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: September 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Dopamine Agonists; Dopamine Agents; Brexpiprazole
• Other Study ID Numbers: 331-201-00195; 2019-002897-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No