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

Sponsor ID
331-201-00195
Clinicaltrials.gov ID
NCT04186403
EudraCT ID
2019-002897-30
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00195
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Borderline Personality Disorder
    • Sex
    Female & Male
    Trial Dates
    Jan 2020 - Sep 2021
    Healthy Volunteers
    No
    • 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.
    • 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 Summary

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

    Additional Study Details

    Phase
    Phase 2/Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    201
    Additional Study Details

    Inclusion and Exclusion Criteria

    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.
    Inclusion and Exclusion Criteria
    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 Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    New York, New York, United States, 10012
    Status
    N/A

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