EUCTR2009-010965-22-NL进行中(未招募)不适用
The effect of long-term simvastatin treatment on cognitive function and daily life in children with Neurofibromatosis 1: a one year randomized controlled trial
Erasmus MC - Department of Pediatrics0 个研究点目标入组 106 人开始时间: 2009年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 106
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
- •Inclusion criteria are: age 8 to 16 years, NF1 diagnosis with genetic confirmation, and oral and written informed consent from parents and participants aged older than 12 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Exclusion criteria are: segmental NF1, pathology of the CNS (other than asymptomatic gliomas), deafness, severely impaired vision, use of ADHD-medication, use of anti-epileptic drugs, use of simvastatin, use of anti-psychotic medication, insufficient comprehension or production of the Dutch language, and an IQ below 48.
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