EUCTR2018-003893-29-GB进行中（未招募）1 期
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 - CASTLE TRIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Children diagnosed with RE
- •b. EEG showing focal sharp waves with normal background
- •c. Aged =5 years and <13 years at the time of randomisation
- •d. Currently untreated with antiepileptic drugs
- •e. Written informed consent received from person with parental responsibility/legal representative.
- •f. Family have a valid email address and regular internet access (for online sleep intervention)
- •g. 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:
- •h. Ability of parent and child to speak conversational English
- •i. Additional consent to main trial: Consent of parent to participate and for their child to participate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •a. Known contraindication to any of the trial drugs
- •b. Previously treated for epilepsy with antiepileptic drugs
研究者
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