EUCTR2011-001571-39-GB进行中（未招募）1 期
Investigating the relationship between sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS): A Randomised Double-Blind Placebo-Controlled Cross-Over Trial. - Sleep Disturbance and Learning in BECCTS
niversity of Bristol0 个研究点目标入组 20 人开始时间: 2011年8月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •-Male and female children 6–16 years of age
- •-Within 6 months of diagnosis with BECCTS and the onset of symptoms
- •-With clinical EEG characteristic consistent with typical BECCTS [16]
- •-With no current or prior treatment for BECCTS
- •-Signed informed (parental) consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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
- •-Inability to comply with assessments
- •-Any serious intercurrent illness or uncontrolled disease which could compromise participation in the study
- •-With contraindications for treatment with sulthiame:
- •-History of hypersensitivity to sulphonamides
- •-History of acute porphyria
- •-History of hyperthyroidism
- •-History of arterial hypertension
- •-Impaired renal function
- •-Psychiatric disorder
- •-Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose
- •malabsorption syndrome.
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