NCT06333964CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AST-001 Followed by an Open-Label Extension Treatment Period in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 169 (actual)
- First submitted
- 21 Mar 2024
- Start date
- 29 Aug 2023
- Primary completion date
- 5 Dec 2024
- Lead sponsor
- Astrogen, Inc.
- Diseases
- Autism
- NCT number
- NCT06333964
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 169
- From 29 Aug 2023 to the primary completion date, 5 Dec 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- At the time of screening, subject has the medical history, concomitant condition, or surgical history
Other illness
- During the screening period, uncontrolled medical conditions,
Other
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hallym University Medical Center Coordinator of this site? Confirm its status | Anyang-si | South Korea | Unknown status |
| Samsung Changwon Medical Center Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| Soon Chun Hyang University Hospital Cheonan Coordinator of this site? Confirm its status | Cheonan | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Koera University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.