protocolSection identificationModule nctId: NCT06333964, orgStudyIdInfo id: AST-001P_P301_ASD, briefTitle: Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-29, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Astrogen, Inc., class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Main study(0\~12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001Extension study(12\~24 weeks) Experimental: AST-001 Comparator: AST-001, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AST-001, interventions name: Placebo of AST-001, outcomesModule primaryOutcomes measure: K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II), secondaryOutcomes measure: CGI (Clinical Global Impression), secondaryOutcomes measure: SRS-2 (Social Responsiveness Scale-2), secondaryOutcomes measure: K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Soon Chun Hyang University Hospital Cheonan, status: RECRUITING, city: Cheonan, state: Chungcheongnam-do, country: Korea, Republic of, geoPoint lat: 36.8065, lon: 127.1522, locations facility: Hallym University Medical Center, status: RECRUITING, city: Anyang, state: Gyeonggi-do, country: Korea, Republic of, geoPoint lat: 37.3925, lon: 126.92694, locations facility: Samsung Changwon Medical Center, status: RECRUITING, city: Changwon, state: Gyeongsangnam-do, country: Korea, Republic of, geoPoint lat: 35.22806, lon: 128.68111, locations facility: Pusan National University Yangsan Hospital, status: RECRUITING, city: Yangsan, state: Gyeongsangnam-do, country: Korea, Republic of, geoPoint lat: 35.34199, lon: 129.03358, locations facility: Jeonbuk National University Hospital, status: RECRUITING, city: Jeonju, state: Jeollabuk-do, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, locations facility: Chungnam National University Hospital, status: RECRUITING, city: Daejeon, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hanyang University Seoul Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Koera University Guro Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: The Catholic University of Korea, Seoul St. Mary's Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False