A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children
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
Timeline
- Start
- 2023-08-29
- Primary completion
- 2024-12-05
- Completion
- 2024-12-05
Outcome
Missed primary endpoint
release “아스트로젠의 자폐 치료 후보물질 ‘AST-001(스페라젠시럽)’에 대해 지난달 유효성을 인정하기 어렵다고 판단했다.” neuroventi.com ↗
release “당초 회사는 2~7세 자폐 아동을 대상으로 한 근본적 치료제 개발을 목표로 했지만 임상에서 유효성을 입증하지 못했다.” neuroventi.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AST-001 | Unknown | — | Oral |