Autism Spectrum Disorder
Conditions
Brief 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
Interventions
DRUGAST-001
AST-001, PO bid for 24weeks (dosage according to weight range)
DRUGPlacebo of AST-001
Placebo of AST-001, PO bid for 12 weeks + AST-001, PO bid for 12 weeks (dosage according to weight range)
Sponsors
Astrogen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Main study(0\ 12 weeks) Experimental: AST-001 Comparator: Placebo of AST-001 Extension study(12\ 24 weeks) Experimental: AST-001 Comparator: AST-001
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Those who meet the criteria of diagnostic and statistical manual of mental disorder (DSM)-5 during screening * During screening period, individuals who are diagnosed with ASD through ADI-R assessment * Subject with a CGI-S score of 4 or higher as a result of Clinical Global Impression(CGI) evaluation during baseline visit(visit 2) * Subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form * In case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial * Subject whose legally authorized representative is able to participate in the provision of reliable information about the subject's condition, execute all scheduled site visits, oversee IP administration, fully understand and speak Korean, and conduct survey evaluation regarding the subject
Exclusion criteria
* At the time of screening, subject has the medical history, concomitant condition, or surgical history * During the screening period, uncontrolled medical conditions, * During the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator * At the time of screening, weight over 60kg * Inappropriate to participate in the trial determined by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II) | Baseline, 12week, 24week |
Secondary
| Measure | Time frame |
|---|---|
| SRS-2 (Social Responsiveness Scale-2) | Baseline, 4week, 12week, 24week |
| K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form) | Baseline, 12week, 24week |
| CGI (Clinical Global Impression) | Baseline, 4week, 8week, 12week, 18week, 24week |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYoo-Sook Joung, MD, Ph.D
Samsung Medical Center
Outcome results
None listed