NCT04600882撤回不适用
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Stalicla SA
- 试验地点
- 1
- 主要终点
- Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
研究概览
简要总结
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
- •At least two well documented head circumference values recorded within the first 2 years of life
- •Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English
排除标准
- •Genetically identified ASD (syndromic form of autism, e.g. fragile X)
- •Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit
结局指标
主要结局
Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
时间窗: Day 0
A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants
次要结局
未报告次要终点
研究者
研究点 (1)
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