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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

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Trial Profile

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: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs AST-001 (Primary)
  • Indications Autism spectrum disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Astrogen

Most Recent Events

  • 02 Feb 2026 Status changed from active, no longer recruiting to completed.
  • 11 Feb 2025 Planned End Date changed from 31 Dec 2024 to 30 Jun 2025.
  • 11 Feb 2025 Status changed from recruiting to active, no longer recruiting.

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