A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of AST-001 in Children with Autism Spectrum Disorder

Not Applicable

Completed

• Conditions: Mental and behavioural disorders

• Registration Number: KCT0007519
• Lead Sponsor: Astrogen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-05-16
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

ASD according to diagnostic and statistical manual of mental disorder(DSM)-5 criteria at screening,
ASD diagnosis confirmed by Autism Diagnostic Interview-Revised(ADI-R) at screening period,
Signed Informed Consent Form,
Availability of a parent or other reliable caregiver who is fluent in Korean. The same person must agree to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms and must agree to oversee the subject's adherence with protocol-specified procedures and study medication dosing

Exclusion Criteria

Medical history, concomittant disease or operation history at screening,
Uncontrolled medical condition including arrhythmia, cancer, severe heart/kidney disease at screening period,
Causing Serious self-injury or harm to others that requires medical intervention during screening period,
Children weighing over 60kg of body weight at screening,
Inappropriate to participate in the trial determined by investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)

Secondary Outcome Measures

Name	Time	Method
CGI (Clinical Global Impression);SRS-2 (Social Responsiveness Scale-2);ABC (Aberrant Behavior Checklist);K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form)