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

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04186403
Collaborator
(none)
201
1
1
20.3
9.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 13, 2020
Actual Primary Completion Date :
Sep 22, 2021
Actual Study Completion Date :
Sep 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Drug

2 to 3 mg per day

Drug: Brexpiprazole
Tablet
Other Names:
  • Rexulti
  • Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (AEs) [Safety] [Up to 12 weeks]

      Frequency and severity of AEs will be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects, 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 subjects must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of IMP.

    • Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.

    • Subjects 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.

    • Subjects who develop a medically significant abnormality.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding sites, contact 844-687-8522 New York New York United States 10012

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Development & Commercialization, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    ClinicalTrials.gov Identifier:
    NCT04186403
    Other Study ID Numbers:
    • 331-201-00195
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021