NCT06333964已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AST-001 Followed by an Open-Label Extension Treatment Period in Children With Autism Spectrum Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 11
- 主要终点
- K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)
研究概览
简要总结
- Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.
- Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.
- Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who meet the criteria of diagnostic and statistical manual of mental disorder (DSM)-5 during screening
- •During screening period, individuals who are diagnosed with ASD through ADI-R assessment
- •Subject with a CGI-S score of 4 or higher as a result of Clinical Global Impression(CGI) evaluation during baseline visit(visit 2)
- •Subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form
- •In case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial
- •Subject whose legally authorized representative is able to participate in the provision of reliable information about the subject's condition, execute all scheduled site visits, oversee IP administration, fully understand and speak Korean, and conduct survey evaluation regarding the subject
排除标准
- •At the time of screening, subject has the medical history, concomitant condition, or surgical history
- •During the screening period, uncontrolled medical conditions,
- •During the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator
- •At the time of screening, weight over 60kg
- •Inappropriate to participate in the trial determined by investigator
研究组 & 干预措施
AST-001
Experimental
干预措施: AST-001 (Drug)
Placebo of AST-001
Placebo Comparator
干预措施: Placebo of AST-001 (Drug)
结局指标
主要结局
K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)
时间窗: Baseline, 12week, 24week
次要结局
- CGI (Clinical Global Impression)(Baseline, 4week, 8week, 12week, 18week, 24week)
- SRS-2 (Social Responsiveness Scale-2)(Baseline, 4week, 12week, 24week)
- K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form)(Baseline, 12week, 24week)
研究者
研究点 (11)
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