AST-001 versus placebo for social communication in children with autism spectrum disorder: A randomized clinical trial.

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,

SUBMITTER: Kim HW 

PROVIDER: S-EPMC11693980 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature