NCT06333964

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

Name: Clinical Trial NCT06333964
Creator: Astrogen, Inc.
Keywords: Autism Spectrum Disorder, AST-001, Phase 3, drug, clinical trial, South Korea

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

Astrogen, Inc.·Phase 3·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Autism Spectrum Disorder
Drug/Device/Intervention: AST-001
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Astrogen, Inc.
Location: Cheonan,Anyang,Changwon,Yangsan,Jeonju,Daejeon,Seoul,Seoul,Seoul,Seoul,Seoul, South Korea

Timeline & enrollment

Phase: Phase 3
Start date: Aug 29, 2023
End date: Dec 31, 2024
Enrollment: 160 participants

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

Childhood autismAtypical autismAsperger syndromeNeurotic disorder, unspecifiedMental and behavioural disorders

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06333964
Type: Non-Device Trial

About this record

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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