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    • AST-001 Versus Placebo for Social Communication in Children with Autism Spectrum Disorder: A Randomized Clinical Trial

    Hyo-Won Kim, Ji-Hoon Kim,Un Sun Chung,Johanna Inhyang Kim,Se-hoon Shim,Tae Won Park,Moon-Soo Lee,Jun-Won Hwang,Eun-Jin Park,Su-Kyeong Hwang,Yoo-Sook Joung

    Psychiatry And Clinical Neurosciences（2024）SCI 3区

    Univ Ulsan | Pusan Natl Univ Hosp | Kyungpook Natl Univ | Hanyang Univ Med Ctr | Jeonbuk Natl Univ | Korea Univ | Kangwon Natl Univ | Inje Univ | Sungkyunkwan Univ

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    Abstract
    Aim: This study examined the efficacy of AST-001 for the core symptoms of autism spectrum disorder (ASD) in children. Methods: This phase 2 clinical trial consisted of a 12-week placebo-controlled main study, a 12-week extension, and a 12-week follow-up in children aged 2 to 11 years with ASD. The participants were randomized in a 1:1:1 ratio to a high-dose, low-dose, or placebo-to-high-dose control group during the main study. The placebo-to-high-dose control group received placebo during the main study and high-dose AST-001 during the extension. The a priori primary outcome was the mean change in the Adaptive Behavior Composite (ABC) score of the Korean Vineland Adaptive Behavior Scales II (K-VABS-II) from baseline to week 12. Results: Among 151 enrolled participants, 144 completed the main study, 140 completed the extension, and 135 completed the follow-up. The mean K-VABS-II ABC score at the 12th week compared with baseline was significantly increased in the high-dose group (P = 0.042) compared with the placebo-to-high-dose control group. The mean CGI-S scores were significantly decreased at the 12th week in the high-dose (P = 0.046) and low-dose (P = 0.017) groups compared with the placebo-to-high-dose control group. During the extension, the K-VABS-II ABC and CGI-S scores of the placebo-to-high-dose control group changed rapidly after administration of high-dose AST-001 and caught up with those of the high-dose group at the 24th week. AST-001 was well tolerated with no safety concern. The most common adverse drug reaction was diarrhea. Conclusions: Our results provide preliminary evidence for the efficacy of AST-001 for the core symptoms of ASD.
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    autism,children,clinical trial,social communication
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    【要点】：本研究探讨了AST-001治疗自闭症谱系障碍(ASD)儿童核心症状的疗效，结果显示AST-001具有初步的治疗效果。
    

    【方法】：采用12周的随机安慰剂对照临床试验，对2至11岁ASD儿童进行高剂量、低剂量AST-001治疗和安慰剂对照。
    

    【实验】：共151名参与者，完成主要研究的144名，完成延长期140名，完成随访135名。结果显示，高剂量组在第12周K-VABS-II ABC评分与基线相比显著增加(P=0.042)，CGI-S评分显著降低(P=0.046)；低剂量组CGI-S评分也显著降低(P=0.017)。在延长期，安慰剂转高剂量组在服用高剂量AST-001后评分迅速提高，第24周时接近高剂量组水平。AST-001耐受性良好，主要不良反应为腹泻。