Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children - Trial NCT06333964
Access comprehensive clinical trial information for NCT06333964 through Pure Global AI's free database. This Phase 3 trial is sponsored by Astrogen, Inc. and is currently Recruiting. The study focuses on Autism Spectrum Disorder. Target enrollment is 160 participants.
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Study Focus
Sponsor & Location
Astrogen, Inc.
Timeline & Enrollment
Phase 3
Aug 29, 2023
Dec 31, 2024
Primary Outcome
K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06333964
Non-Device Trial