NL-OMON39487已完成2 期
Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial) - RAPIT-trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Children with a definite diagnosis of TSC between 4 and 17 years.
- •Estimated IQ <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.
排除标准
- •Hepatic dysfunction.
- •Surgery less than 6 weeks before entering the study.
- •Infection at time of inclusion.
- •Allergy for any of the components of the study medication.
- •Additional diseases or disorders that may influence the endpoints.
- •Developmental age estimated below 3.5 years.
- •Intractable epilepsy with more than 1 seizure per week.
研究者
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