A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- All serious adverse events reported; visits scheduled every 3 months
研究概览
简要总结
The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.
详细描述
Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.
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
- •Participation in the previous SCoP study, 99824
- •Still fulfils the EU SPC requirements for Sertindole
排除标准
- •Withdrawn before the end of the SCoP study, 99824
- •Become homeless
- •Participation in another clinical trial at the same time
- •Unlikely to comply with the clinical study protocol or is unsuitable for any reason
研究组 & 干预措施
Sertindole
干预措施: Sertindole (Drug)
结局指标
主要结局
All serious adverse events reported; visits scheduled every 3 months
时间窗: Every 3 months
次要结局
未报告次要终点