跳至主要内容
临床试验/NCT00393614
NCT00393614Unknown4 期

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年5月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
试验地点
2
主要终点
24 hour EEG

研究概览

简要总结

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 5-10 years

排除标准

  • 未提供

结局指标

主要结局

24 hour EEG

时间窗: End of the study

次要结局

  • Health related quality of life(End of the study)
  • Neuro-psychological testing,(End of the study)
  • Behavioral problems(End of the study)

研究者

发起方
Oslo University Hospital
申办方类型
Other

研究点 (2)

Loading locations...

相似试验