Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
研究概览
简要总结
Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.
A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 12 years and above
- •epilepsy patients
- •indication to initiation / conversion to valproate sustained release minitablets once daily
排除标准
- •contraindication to valproate use
- •no indication for conversion to valproate sustained release minitablets once daily
研究组 & 干预措施
1
epilepsy patients
干预措施: sodium valproate (Drug)
结局指标
主要结局
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
时间窗: 7 weeks
Number of Seizures Within 7 Weeks
时间窗: 7 weeks
次要结局
- Data About Efficacy, Safety and Compliance(7 weeks)