- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06333964
Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children
March 21, 2024 updated by: Astrogen, Inc.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 Followed by an Open-Label Extension Treatment Period in Children With Autism Spectrum Disorder
- 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.
- 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.
- Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyun Kwon
- Phone Number: +82-10-4336-6061
- Email: imhyun@astrogen.co.kr
Study Contact Backup
- Name: Sangmin Park
- Phone Number: +82-10-4266-7972
- Email: psm0815music@astrogen.co.kr
Study Locations
-
-
-
Daejeon, Korea, Republic of
- Recruiting
- Chungnam National University Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Asan Medical Center
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Seoul, Korea, Republic of
- Recruiting
- Hanyang University Seoul Hospital
-
Seoul, Korea, Republic of
- Recruiting
- Koera University Guro Hospital
-
Seoul, Korea, Republic of
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
-
Chungcheongnam-do
-
Cheonan, Chungcheongnam-do, Korea, Republic of
- Recruiting
- Soon Chun Hyang University Hospital Cheonan
-
-
Gyeonggi-do
-
Anyang, Gyeonggi-do, Korea, Republic of
- Recruiting
- Hallym University Medical Center
-
-
Gyeongsangnam-do
-
Changwon, Gyeongsangnam-do, Korea, Republic of
- Recruiting
- Samsung Changwon Medical Center
-
Yangsan, Gyeongsangnam-do, Korea, Republic of
- Recruiting
- Pusan National University Yangsan Hospital
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of
- Recruiting
- Jeonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AST-001
|
AST-001, PO bid for 24weeks (dosage according to weight range)
|
Placebo Comparator: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II)
Time Frame: Baseline, 12wk, 24wk
|
Baseline, 12wk, 24wk
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CGI (Clinical Global Impression)
Time Frame: Baseline, 4wk, 8wk, 12wk, 18wk, 24wk
|
Baseline, 4wk, 8wk, 12wk, 18wk, 24wk
|
SRS-2 (Social Responsiveness Scale-2)
Time Frame: Baseline, 4wk, 12wk, 24wk
|
Baseline, 4wk, 12wk, 24wk
|
K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form)
Time Frame: Baseline, 12wk, 24wk
|
Baseline, 12wk, 24wk
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoo-Sook Joung, MD, Ph.D, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 21, 2024
First Submitted That Met QC Criteria
March 21, 2024
First Posted (Actual)
March 27, 2024
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AST-001P_P301_ASD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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