A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy

UCB Pharma0 个研究点目标入组 1,000 人开始时间: 2007年4月最近更新: 2012年7月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: UCB Pharma
入组人数: 1,000

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. Adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

年龄范围: 4 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and female patients from the age of 4 years
•Confirmed diagnosis of epilepsy requiring AED treatment
•Patients already receiving daily AED treatment as a monotherapy or a polytherapy with maximum 2 AEDs within the terms of marketing authorization with the following medications: Carbamazepine, Clobazam, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenobarbital, Phenytoin, Pregabalin, Tiagabine, Topiramate, Valproate, Zonisamide
•Treatment must be stable for at least 3 months prior to assessment
•Absence of other severe and/or uncontrolled symptomatic chronic illness

排除标准

未提供

研究者

发起方

UCB Pharma

申办方类型

Industry

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