Condition: Autism Spectrum Disorder · Sponsor: Astrogen, Inc.
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
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| Soon Chun Hyang University Hospital Cheonan | Cheonan, Chungcheongnam-do, South Korea | — |
| Hallym University Medical Center | Anyang-si, Gyeonggi-do, South Korea | — |
| Samsung Changwon Medical Center | Changwon, Gyeongsangnam-do, South Korea | — |
| Pusan National University Yangsan Hospital | Yangsan, Gyeongsangnam-do, South Korea | — |
| Jeonbuk National University Hospital | Jeonju, Jeollabuk-do, South Korea | — |
| Chungnam National University Hospital | Daejeon, South Korea | — |
| Asan Medical Center | Seoul, South Korea | — |
| Hanyang University Seoul Hospital | Seoul, South Korea | — |
| Koera University Guro Hospital | Seoul, South Korea | — |
| Samsung Medical Center | Seoul, South Korea | — |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul, South Korea | — |
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