跳至主要内容
临床试验/EUCTR2010-019519-39-NL
EUCTR2010-019519-39-NL进行中(未招募)不适用

Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial) - RAPIT

Erasmus MC - Department of Neurology0 个研究点开始时间: 2011年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Children with a definite diagnosis of TSC between 3 and 18 years.
  • With an IQ estimated <80 and/or special schooling and/or autism spectrum disorder and/or learning disability
  • requiring remedial teaching.
  • Written informed consent by parents/care-takers, and the patient if he or she is 12 years or older and cognitively
  • able to consent.
  • In girls after menarche, appropriate contraception must be used or abstinence practiced.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 60
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Renal or liver dysfunction
  • Surgery <6wk before entering the study
  • Current infection at time of inclusion
  • Additional diseases or disorders that may influence the endpoints
  • Allergy for any of the components of the study medication

研究者

发起方
Erasmus MC - Department of Neurology

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