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Study identifier: NCT06333964 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Completed

A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children

Condition: Autism Spectrum Disorder  ·  Sponsor: Astrogen, Inc.

PhasePhase 3
Planned participants169
Who can joinAll sexes, 2 Years to 7 Years
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (11)

Soon Chun Hyang University Hospital CheonanCheonan, Chungcheongnam-do, South Korea
Hallym University Medical CenterAnyang-si, Gyeonggi-do, South Korea
Samsung Changwon Medical CenterChangwon, Gyeongsangnam-do, South Korea
Pusan National University Yangsan HospitalYangsan, Gyeongsangnam-do, South Korea
Jeonbuk National University HospitalJeonju, Jeollabuk-do, South Korea
Chungnam National University HospitalDaejeon, South Korea
Asan Medical CenterSeoul, South Korea
Hanyang University Seoul HospitalSeoul, South Korea
Koera University Guro HospitalSeoul, South Korea
Samsung Medical CenterSeoul, South Korea
The Catholic University of Korea, Seoul St. Mary's HospitalSeoul, South Korea

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