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

NCT04186403 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 331-201-001952019-002897-30
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

  Screening up to Week 12

• Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

  Screening up to Week 12

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

  Screening up to Week 12

• Change From Baseline in Simpson-Angus Scale (SAS) Total Score

  Baseline and Week 12

• Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

  Baseline and Week 12

Study Arms (2)

Prior Brexpiprazole 2-3 Milligrams Per Day

EXPERIMENTAL

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

Prior Placebo

EXPERIMENTAL

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

Interventions

Brexpiprazole DRUG

Administered as tablets.

Also known as: Rexulti, OPC-34712

Prior Brexpiprazole 2-3 Milligrams Per Day; Prior Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

For additional information regarding sites, contact 844-687-8522

New York, New York, 10012, United States

Location

Related Publications (1)

• Rothman B, Brewer C, Chang D, Hobart M, Hefting N, McQuade RD, Grant JE. A randomised study and an extension study of brexpiprazole in patients with borderline personality disorder. Acta Neuropsychiatr. 2024 Nov 19;37:e39. doi: 10.1017/neu.2024.31.

  PMID: 39558901 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: January 13, 2020
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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

Locations

US (1)