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

Last updated: September 9, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

2/3

Condition

Borderline Personality Disorder

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

Brexpiprazole

Clinical Study ID

NCT04186403
331-201-00195
2019-002897-30
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants, who completed the last treatment visit of the previous double-blindbrexpiprazole BPD trial and who, in the opinion of the investigator, couldpotentially benefit from administration of brexpiprazole for the treatment of BPD.

  • Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informedconsent of the previous double-blind brexpiprazole BPD trial.

Exclusion

Exclusion Criteria:

  • Sexually active males or females of childbearing potential (FOCBP) who do not agreeto practice 2 different methods of birth control or remain abstinent during thetrial and for 30 days after the last dose of IMP. Male participants must also agreenot to donate sperm from trial screening/baseline through 30 days after the lastdose of investigational medicinal product (IMP).

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

  • Participants who participated in a clinical trial within 90 days prior toscreening/baseline (with the exception of a previous brexpiprazole double-blind BPDtrial) or who participated in more than 2 clinical trials within a year prior toscreening/baseline.

  • Participants who develop a medically significant abnormality.

Study Design

Total Participants: 201
Treatment Group(s): 1
Primary Treatment: Brexpiprazole
Phase: 2/3
Study Start date:
January 13, 2020
Estimated Completion Date:
September 22, 2021

Connect with a study center

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

    New York, New York 10012
    United States

    Site Not Available

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