ISRCTN12839803终止未知
Randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention in treatment naive children with rolandic epilepsy
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children diagnosed with RE
- •2. EEG showing focal sharp waves with normal background
- •3. Aged >=5 years and <13 years at the time of randomisation
- •4. Currently untreated with antiepileptic drugs
- •5. Written informed consent received from person with parental responsibility/legal representative.
- •6. Family have a valid email address and regular internet access (for online sleep intervention)
- •7. Parent and child are to have a good understanding of the English language.
- •Parent-child dyads meeting the trial criteria and the following characteristics will be eligible for inclusion in the qualitative sub-study:
- •1 Ability of parent and child to speak conversational English
- •2 Additional consent to main trial: Consent of parent to participate and for their child to participate
排除标准
- •1. Known contraindication to any of the trial drugs
- •2. Previously treated for epilepsy with antiepileptic drugs
研究者
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