EUCTR2007-000565-37-GB进行中(未招募)1 期
A Prospective Study to Determine the Adverse Drug Reactions Profile of Anticonvulsants in Children - A Study of Adverse Drug Reactions to Anticonvulsants in Children
niversity of Nottingham0 个研究点目标入组 300 人开始时间: 2007年7月31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
- 300
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
- •1.Children (aged 0-16 years) attending outpatient clinics, as well as inpatients, who are receiving one or more anticonvulsants for epilepsy (Group A).
- •2.Children aged 4-16 years commencing anticonvulsant therapy for epilepsy for the first time (for group B)
- •3.Children aged 4-16 years who may stop taking anticonvulsant therapy for epilepsy in the following year (for group C)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of any concomitant condition or circumstances which, in the opinion of the investigator, would render the patient unsuitable for the study, such as a known history of alcohol or drug abuse.
- •2. Children aged under 4 years and those aged 4-16 years with significant pre-existing learning difficulties will be excluded from the cognitive and behavioural assessment portion of the study (groups B & C) as no standardised assessments exist for these groups of patients.
研究者
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