Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

UCB Pharma0 个研究点目标入组 342 人开始时间: 2002年1月最近更新: 2013年11月15日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: UCB Pharma
入组人数: 342
主要终点: Adverse event rates, seizure counts and quality of life.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Male and female older than 16 years;
•Epilepsy with partial onset seizures, with or without secondary generalization;
•At least one concomitant marketed anti-epileptic drug

排除标准

•Safety reasons

结局指标

主要结局

Adverse event rates, seizure counts and quality of life.

时间窗: 16 week treatment period

次要结局

未报告次要终点

研究者

发起方

UCB Pharma

申办方类型

Industry

相似试验

已完成

4 期

IV Keppra in the Emergency Department for Prevention of Early Recurrent SeizuresTonic-clonic Seizure

NCT00510783Emory University158

已完成

2 期

Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron DiseaseAmyotrophic Lateral SclerosisPrimary Lateral SclerosisProgressive Muscular AtrophyMotor Neuron Disease

NCT00324454Duke University20

撤回

2 期

Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot StudySeizure, Alcohol Related

NCT00627133Medical University of South Carolina

已完成

4 期

A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in EpilepsyEpilepsy

NCT00631150UCB Pharma35

已完成

4 期

Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial EpilepsyEpilepsy

NCT00630357UCB Pharma14