EUCTR2015-000955-25-FR进行中（未招募）1 期
Evaluation of the efficiency of folinic acid in children with autism spectrum disorders: a pilot study EFFET - EFFET
Centre Hospitalier Régional Universitaire de Nancy0 个研究点目标入组 40 人开始时间: 2015年6月19日最近更新:
适应症
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
- 40
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
- •1)Children with autism spectrum disorders defined by : Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI), Childhood Autism Rating Scale (CARS) or diagnosed by a physician (pediatrician, child psychiatrist)
- •2)Children aged 3 to 10 years
- •3)Weight> 10 kg
- •4)Language impairment (based on the medical assessment)
- •5)Ability to maintain other therapies started before the study
- •6)No changes of therapeutic treatments within the 8 weeks before the start of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
- •1)Treatment may impair folate metabolism (methotrexate, anticonvuslivants : phenobarbital sodium valproate, phenytoin, primidone, carbamazepine, valproic acid, divalproex, antibiotics : tetracycline, trimethoprim, pyrimethamine, inhibitors of proton pump inhibitors of histamine-2)
- •2)Antipsychotic treatment (including treatment with Risperidone)
- •3)Vitamin or mineral supplementation exceeding guidelines
- •4)Children with severe irritability (Aberrant Behavior Checklist> 17)
- •5)Gastroesophageal reflux disease
- •6)Any known renal or liver disease
- •7)Child born premature (<37SA)
- •8)Known intolerance to lactose
- •9)Hypersensitivity / allergic reaction to calcium folinate
- •10)The sibling children with autism spectrum disorders
研究者
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