CTRI/2009/091/000953已完成2 期
A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients with Schizophrenia.
Otsuka Pharmaceutical Development Commercialization9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年1月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- The primary evaluation of safety and tolerability will be through frequency and severity of AEs.
研究概览
简要总结
This will be a multicenter, 6-week, open-label study designed to assess the safety, tolerability, and efficacy of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. Enrollment into the study will be drawn from eligible subjects who have completed participation in Protocol 331-07-203 (CTRI/2009/091/000952) and who, in the investigator's judgment, could potentially benefit from treatment with oral OPC-34712 for schizophrenia. The study is to be conducted on an outpatient basis. From India, 75 subjects will be screened. The tentative date of first patient enrollment in India is January 18, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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 as rescue therapy at Week 4 or Week
- •4.Outpatient status at last visit of Protocol 331-07-203.
排除标准
- •1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.Target Disease, Medical History, and Concurrent Diseases2.Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203.3.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-
- •4.Subjects who represent a risk of committing suicide.Prohibited Therapies or Medications5.Subjects who would be likely to require prohibited concomitant therapy during the study Other6.Any subject who, in the opinion of the investigator, should not participate in the study.
结局指标
主要结局
The primary evaluation of safety and tolerability will be through frequency and severity of AEs.
时间窗: 6 weeks
次要结局
- Change from baseline in PANSS Total Score Change from baseline in Clinical Global Impression - Severity of Illness scale (CGIS) score Change from baseline in Personal and Social Performance scale (PSP) Total Score Mean CGI-I score Change from baseline in PANSS positive subscale score Change from baseline in PANSS negative subscale score Response rate, defined as reduction of ≥ 30% from baseline in PANSS Total Score OR CGI-I score of 1 (very much improved) or 2 (much improved) ? Discontinuation rate for lack of efficacy(6 weeks)
研究者
研究点 (9)
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