Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333964
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-21
Brief Title:
A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children
Sponsor:
Astrogen Inc
Organization:
Astrogen Inc
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None