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

Phase 2

Completed

Conditions: Borderline Personality Disorder

Interventions: Drug: Brexpiprazole

Registration Number: NCT04186403

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 201

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prior Placebo	Brexpiprazole	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.
Prior Brexpiprazole 2-3 Milligrams Per Day	Brexpiprazole	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity	Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities	Screening up to Week 12	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.
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities	Screening up to Week 12	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%).
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score	Baseline and Week 12	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.
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities	Screening up to Week 12	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).
Change From Baseline in Simpson-Angus Scale (SAS) Total Score	Baseline and Week 12	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.
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score	Baseline and Week 12	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.
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Baseline up to Week 12	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.