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Multicenter, Open-label, Safety and Tolerability Study

NCT ID: NCT01649557

Last Updated: 2015-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-09-30

Brief Summary

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This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label OPDC-34712

Group Type EXPERIMENTAL

OPC-34712

Intervention Type DRUG

oral administered once daily

Interventions

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OPC-34712

oral administered once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia.
2. Outpatient status at last visit of Study 331-07-203.

Exclusion Criteria

1. Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide.
2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
5. Subjects who represent a risk of committing suicide based on an answer of "Yes" to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A subject who has had any suicidal ideation within the last 6 months, any suicidal behaviors within the last two years, or who in the clinical judgment of the investigator presents a serious risk of suicide should be excluded from the study.
6. Subjects who would be likely to require prohibited concomitant therapy during the study.
7. Any subject who, in the opinion of the investigator, should not participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Otsuka Investigational Site

Little Rock, Arkansas, United States

Site Status

Otsuka Investigational Site

Escondido, California, United States

Site Status

Otsuka Investigational Site

Garden Grove, California, United States

Site Status

Otsuka Investigational Site

Long Beach, California, United States

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Otsuka Investigational Site

Oceanside, California, United States

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Otsuka Investigational Site

Pasadena, California, United States

Site Status

Otsuka Investigational Site

San Diego, California, United States

Site Status

Otsuka Investigational Site

San Diego, California, United States

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Otsuka Investigational Site

Santa Ana, California, United States

Site Status

Otsuka Investigational Site

Washington D.C., District of Columbia, United States

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Otsuka Investigational Site

Bradenton, Florida, United States

Site Status

Otsuka Investigational Site

Maitland, Florida, United States

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Otsuka Investigational Site

St Louis, Missouri, United States

Site Status

Otsuka Investigational Site

Cedarhurst, New York, United States

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Otsuka Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Otsuka Investigational Site

Austin, Texas, United States

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Otsuka Investigational Site

Burgas, , Bulgaria

Site Status

Otsuka Investigational Site

Kazanlak, , Bulgaria

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Otsuka Investigational Site

Pazardzhik, , Bulgaria

Site Status

Otsuka Investigational Site

Plovdiv, , Bulgaria

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Otsuka Investigational Site

Radnevo, , Bulgaria

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Otsuka Investigational Site

Rousse, , Bulgaria

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Otsuka Investigational Site

Rijeka, , Croatia

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Otsuka Investigational Site

Zagreb, , Croatia

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Otsuka Investigational Site

Vijaywada, Andh Prad, India

Site Status

Otsuka Investigational Site

Visakhapatnam, Andh Prad, India

Site Status

Otsuka Investigational Site

Ahmedabad, Gujarat, India

Site Status

Otsuka Investigational Site

Bangalore, Karna, India

Site Status

Otsuka Investigational Site

Mangalore, Karna, India

Site Status

Otsuka Investigational Site

Mangalore, Karna, India

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Otsuka Investigational Site

Pune, Mahara, India

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Otsuka Investigational Site

Chennai, Tamil Nadu, India

Site Status

Otsuka Investigational Site

Varanasi, Uttar Prad, India

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Otsuka Investigational Site

Cebu City, , Philippines

Site Status

Otsuka Investigational Site

Mandaluyong, , Philippines

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Otsuka Investigational Site

Arad, , Romania

Site Status

Otsuka Investigational Site

Bucharest, , Romania

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Otsuka Investigational Site

Bucharest, , Romania

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Otsuka Investigational Site

Cluj-Napoca, , Romania

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Otsuka Investigational Site

Oradea, , Romania

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Otsuka Investigational Site

Moscow, , Russia

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Otsuka Investigational Site

Moscow Region, , Russia

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Otsuka Investigational Site

Saint Petersburg, , Russia

Site Status

Otsuka Investigational Site

Saint Petersburg, , Russia

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Otsuka Investigational Site

Saint Petersburg, , Russia

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Otsuka Investigational Site

Zagorodnoye, , Russia

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Otsuka Investigational Site

Belgrade, , Serbia

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Otsuka Investigational Site

Kragujevac, , Serbia

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Otsuka Investigational Site

NoviSad, , Serbia

Site Status

Otsuka Investigational Site

Bojnice, , Slovakia

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Otsuka Investigational Site

Bratislava, , Slovakia

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Otsuka Investigational Site

Liptovský Mikuláš, , Slovakia

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Otsuka Investigational Site

Rimavská Sobota, , Slovakia

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Otsuka Investigational Site

Žilina, , Slovakia

Site Status

Otsuka Investigational Site

Chuncheon, , South Korea

Site Status

Otsuka Investigational Site

Incheon, , South Korea

Site Status

Otsuka Investigational Site

Incheon, , South Korea

Site Status

Otsuka Investigational Site

Seoul, , South Korea

Site Status

Otsuka Investigational Site

Hualien City, , Taiwan

Site Status

Otsuka Investigational Site

Taipei, , Taiwan

Site Status

Otsuka Investigational Site

Chernihiv, , Ukraine

Site Status

Otsuka Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

Otsuka Investigational Site

Kyiv, , Ukraine

Site Status

Otsuka Investigational Site

Kyiv, , Ukraine

Site Status

Otsuka Investigational Site

Kyiv, , Ukraine

Site Status

Otsuka Investigational Site

Simferopol, , Ukraine

Site Status

Otsuka Investigational Site

Stepanovka, , Ukraine

Site Status

Otsuka Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

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United States Bulgaria Croatia India Philippines Romania Russia Serbia Slovakia South Korea Taiwan Ukraine

References

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Kane JM, Skuban A, Hobart M, Ouyang J, Weiller E, Weiss C, Correll CU. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia. Schizophr Res. 2016 Jul;174(1-3):93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14.

Reference Type DERIVED
PMID: 27188270 (View on PubMed)

Other Identifiers

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331-08-210

Identifier Type: -

Identifier Source: org_study_id

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