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临床试验/EUCTR2007-000565-37-GB
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

发起方
niversity of Nottingham

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