A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 113
- 主要终点
- Clinical Global Impression of Change (CGI-C) at Month 6
研究概览
简要总结
The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
- •The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
- •The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
- •The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
- •Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®
排除标准
- •In accordance with the Summary of Product Characteristics (SmPC)
结局指标
主要结局
Clinical Global Impression of Change (CGI-C) at Month 6
时间窗: Month 6
For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse
次要结局
- Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6(From Baseline to Month 6)
- Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3(From Baseline to Month 3)
- Incidence of Adverse Events During the Study(From Inclusion Visit (Day 0) up to Month 6)
- Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3(From Baseline to Month 3)
- Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6(From Baseline to Month 6)