Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder
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 |
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Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Study Drug 2 to 3 mg per day |
Drug: Brexpiprazole
Tablet
Other Names:
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Outcome Measures
Primary Outcome Measures
- Adverse Events (AEs) [Safety] [Up to 12 weeks]
Frequency and severity of AEs will be assessed
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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:
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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.
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Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
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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.
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Subjects who develop a medically significant abnormality.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 331-201-00195