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临床试验/NCT00181116
NCT00181116已完成4 期

Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2005年3月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
6
试验地点
1
主要终点
Language improvement

研究概览

简要总结

This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

详细描述

This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Ages 6-12
  • •Benign rolandic epilepsy
  • •Language difficulties as reported by parents or teachers
  • •On another anticonvulsant other than levetiracetam

排除标准

  • •Prior use of levetiracetam
  • •On 2 or more anticonvulsants
  • •Language problems prior to epilepsy
  • •Another seizure disorder
  • •Status epilepticus within the past 6 months
  • •Significant psychiatric disease
  • •Progressive neurologic disease

结局指标

主要结局

Language improvement

次要结局

  • Seizure control

研究者

申办方类型
Other

研究点 (1)

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