An Open-label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)
研究概览
简要总结
The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.
详细描述
This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, suffering from schizophrenia, having completed studies 10206 or 10265
- •Otherwise healthy
- •Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception
- •The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)
排除标准
- •Current Axis I primary psychiatric diagnosis other than schizophrenia
- •Significant risk of suicide and/or violent behaviour
- •Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
- •Substance or alcohol abuse, current cannabis dependence
- •Clinically significant physical illness
研究组 & 干预措施
Bifeprunox
干预措施: Bifeprunox (Drug)
结局指标
主要结局
Adverse events, clinical safety laboratory tests, vital signs, ECGs, physical and neurological examinations, abnormal movement scales (AIMS, BARS, SAS)
时间窗: Assessments every 4 to 8 weeks
次要结局
- CGI-S(Assessments every 4 to 8 weeks)