A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of OralOPC-34712 as Monotherapy in Adult Patients with Schizophrenia

• Conditions: schizophrenia; MedDRA version: 12.0Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2009-012568-14-SK
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-12
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
2. Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion and discontinuation of prohibited concomitant medication; and to be reliably rated on assessment scales.
3. Subjects who participated in 331-07-203 and who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 for the treatment of schizophrenia. Eligible subjects include those who completed participation in the Treatment Phase of Protocol 331-07-203 (ie, Week 6 visit), including subjects who initiated open-label OPC-34712 at Week 4 or Week 5 in the non-responder open-label arm of Protocol 331-07-203.
4. Outpatient status at last visit of Protocol 331-07-203. Hospitalization for psychosocial reasons (eg, homelessness or need for shelter that is unrelated to the subject’s underlying psychiatric condition) will be considered outpatient status for the purpose of enrollment in Protocol 331-08-210. Subjects remaining in hospital
at the Week 6 visit of Protocol 331-07-203 (for other than psychosocial reasons) will be permitted to enroll in Protocol 331-08-210 at the Week 6 visit of Protocol 331-07-203 if they are planned to be discharged from the hospital before the Week 1 visit of Protocol 331-08-210.
5. Subjects who qualify for Protocol 331-08-210 at the Week 6 visit of Protocol 331-07-203 and can continue therapy without interruption between the double-blind and open-label studies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
3. Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203. Minor violations such as visits outside of the acceptable window or a missing blood draw will not exclude a subject from participation in Protocol 331-08-210; however, continual lack of compliance with the visit schedule, study assessments, or treatment regimen in Protocol 331-07-203 would be considered a major violation that would result in exclusion from Protocol 331-08-
210. The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.
4. Subjects who do not continue to meet all applicable inclusion/exclusion criteria for Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203. If data from Week 6 are not available to assess eligibility (eg, results of clinical laboratory tests obtained at Week 6), the assessment for the affected criteria should be based on the last available measurement during Protocol 331-07-203. The medical monitor should be contacted if the investigator is unsure of a subject’s eligibility.
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 (refer to Section 4.1 of protocol).
7. Any subject who, in the opinion of the investigator, should not participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess the long term efficacy of oral OPC-34712 as monotherapy in adult patients with schizophrenia.;Primary end point(s): The primary evaluation of safety and tolerability will be through frequency and severity of AEs.<br>;Main Objective: To assess the long term safety and tolerability of oral OPC-34712 as monotherapy in adult patients with schizophrenia. This study is to be conducted on an outpatient basis.