Multicenter, Open-label, Safety and Tolerability Study

NCT01649557 | Completed Phase 2 Results DMC

• 1 other identifier: 331-08-210
• Study Type: interventional
• Target: 244
• Locations: 12 countries
• Sites: 68

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) During First 6 Weeks.

  AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.

  From Baseline up to 6 weeks

• Number of Participants With AEs in 52-Week Enrollers.

  AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.

  From Baseline up to 52 weeks

Secondary Outcomes (8)

• Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.

  Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit

• Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.

  Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit

• Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.

  Baseline, Week 1, 2, 6, 26, 52 and Last Visit

• Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.

  Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit

• Change From Baseline in PANSS Positive Subscale Score.

  Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit

Study Arms (1)

Open-label OPDC-34712

EXPERIMENTAL

Drug: OPC-34712

Interventions

OPC-34712 DRUG

oral administered once daily

Open-label OPDC-34712

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Outpatient status at last visit of Study 331-07-203.

You may not qualify if:

• 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.
• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.
• 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.
• Subjects who would be likely to require prohibited concomitant therapy during the study.
• Any subject who, in the opinion of the investigator, should not participate in the study.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (68)

Otsuka Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Otsuka Investigational Site

Escondido, California, 92025, United States

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Otsuka Investigational Site

Garden Grove, California, 92845, United States

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Otsuka Investigational Site

Long Beach, California, 90813, United States

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Otsuka Investigational Site

Oceanside, California, 92056, United States

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Otsuka Investigational Site

Pasadena, California, 91106, United States

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Otsuka Investigational Site

San Diego, California, 92102, United States

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Otsuka Investigational Site

San Diego, California, 92123, United States

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Otsuka Investigational Site

Santa Ana, California, 92701, United States

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Otsuka Investigational Site

Washington D.C., District of Columbia, 20016, United States

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Otsuka Investigational Site

Bradenton, Florida, 34208, United States

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Otsuka Investigational Site

Maitland, Florida, 32751, United States

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Otsuka Investigational Site

St Louis, Missouri, 63118, United States

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Otsuka Investigational Site

Cedarhurst, New York, 11516, United States

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Otsuka Investigational Site

Philadelphia, Pennsylvania, 19139, United States

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Otsuka Investigational Site

Austin, Texas, 78731, United States

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Otsuka Investigational Site

Burgas, 8000, Bulgaria

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Otsuka Investigational Site

Kazanlak, 6100, Bulgaria

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Otsuka Investigational Site

Pazardzhik, 4400, Bulgaria

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Otsuka Investigational Site

Plovdiv, 4002, Bulgaria

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Otsuka Investigational Site

Radnevo, 6260, Bulgaria

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Otsuka Investigational Site

Rousse, 7003, Bulgaria

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Otsuka Investigational Site

Rijeka, 51 000, Croatia

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Otsuka Investigational Site

Zagreb, 10 090, Croatia

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Otsuka Investigational Site

Vijaywada, Andh Prad, 520002, India

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Otsuka Investigational Site

Visakhapatnam, Andh Prad, 530017, India

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Otsuka Investigational Site

Ahmedabad, Gujarat, 380015, India

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Otsuka Investigational Site

Bangalore, Karna, 560010, India

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Otsuka Investigational Site

Mangalore, Karna, 575001, India

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Otsuka Investigational Site

Mangalore, Karna, 575018, India

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Otsuka Investigational Site

Pune, Mahara, 411 004, India

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Otsuka Investigational Site

Chennai, Tamil Nadu, 600003, India

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Otsuka Investigational Site

Varanasi, Uttar Prad, 221005, India

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Otsuka Investigational Site

Cebu City, 6000, Philippines

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Otsuka Investigational Site

Mandaluyong, 1553, Philippines

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Otsuka Investigational Site

Arad, 310022, Romania

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Otsuka Investigational Site

Bucharest, 010825, Romania

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Otsuka Investigational Site

Bucharest, 041914, Romania

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Otsuka Investigational Site

Cluj-Napoca, 400012, Romania

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Otsuka Investigational Site

Oradea, 410154, Romania

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Otsuka Investigational Site

Moscow, 115522, Russia

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Otsuka Investigational Site

Moscow Region, 141371, Russia

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Otsuka Investigational Site

Saint Petersburg, 190121, Russia

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Otsuka Investigational Site

Saint Petersburg, 193167, Russia

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Otsuka Investigational Site

Saint Petersburg, 197341, Russia

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Otsuka Investigational Site

Zagorodnoye, 117152, Russia

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Otsuka Investigational Site

Belgrade, 11000, Serbia

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Otsuka Investigational Site

Kragujevac, 34000, Serbia

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Otsuka Investigational Site

NoviSad, 21000, Serbia

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Otsuka Investigational Site

Bojnice, 92701, Slovakia

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Otsuka Investigational Site

Bratislava, 82606, Slovakia

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Otsuka Investigational Site

Liptovský Mikuláš, 03123, Slovakia

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Otsuka Investigational Site

Rimavská Sobota, 97912, Slovakia

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Otsuka Investigational Site

Žilina, 01207, Slovakia

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Otsuka Investigational Site

Chuncheon, 200-704, South Korea

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Otsuka Investigational Site

Incheon, 400-711, South Korea

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Otsuka Investigational Site

Incheon, 405-760, South Korea

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Otsuka Investigational Site

Seoul, 143-711, South Korea

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Otsuka Investigational Site

Hualien City, 981, Taiwan

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Otsuka Investigational Site

Taipei, 249, Taiwan

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Otsuka Investigational Site

Chernihiv, 14005, Ukraine

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Otsuka Investigational Site

Dnipropetrovsk, 49005, Ukraine

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Otsuka Investigational Site

Kyiv, 02660, Ukraine

Location

Otsuka Investigational Site

Kyiv, 04080, Ukraine

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Otsuka Investigational Site

Kyiv, 04655, Ukraine

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Otsuka Investigational Site

Simferopol, 95006, Ukraine

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Otsuka Investigational Site

Stepanovka, 73488, Ukraine

Location

Otsuka Investigational Site

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 27188270 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 29, 2015
• Results First Posted: October 29, 2015

Record last verified: 2015-09

Locations

IN (9); KR (4); BU (6); CR (2); TW (2); SE (3); RU (6); UA (8); SL (5); US (16); RO (5); PH (2)