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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

August 29, 2023

Primary Completion Date

December 5, 2024

Study Completion Date

June 30, 2025

Conditions
Autism Spectrum Disorder
Interventions
DRUG

AST-001

AST-001, PO bid for 24weeks (dosage according to weight range)

DRUG

Placebo of AST-001

Placebo of AST-001, PO bid for 12 weeks + AST-001, PO bid for 12 weeks (dosage according to weight range)

Trial Locations (11)

Unknown

Soon Chun Hyang University Hospital Cheonan, Cheonan

Hallym University Medical Center, Anyang-si

Samsung Changwon Medical Center, Changwon

Pusan National University Yangsan Hospital, Yangsan

Jeonbuk National University Hospital, Jeonju

Chungnam National University Hospital, Daejeon

Asan Medical Center, Seoul

Hanyang University Seoul Hospital, Seoul

Koera University Guro Hospital, Seoul

Samsung Medical Center, Seoul

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

All Listed Sponsors
lead

Astrogen, Inc.

INDUSTRY

NCT06333964 - A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children | Biotech Hunter | Biotech Hunter