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Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children

Autism Spectrum Disorder Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 Followed by an Open-Label Extension Treatment Period in Children With Autism Spectrum Disorder

Clinical Trial Summary

1. 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. 2. 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. 3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06333964
Study type Interventional
Source Astrogen, Inc.
Contact Hyun Kwon
Phone +82-10-4336-6061
Email imhyun@astrogen.co.kr
Status Recruiting
Phase Phase 3
Start date August 29, 2023
Completion date December 31, 2024
View Details
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