AST-001 / Astrogen - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children (clinicaltrials.gov) - P3 | N=169 | Active, not recruiting | Sponsor: Astrogen, Inc. | Trial completion date: Dec 2024 ➔ Jun 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Autism Spectrum Disorder • Genetic Disorders

Response to [Examining the feasibility and limitations of AST-001 as a treatment for autism spectrum disorder]. (PubMed, Psychiatry Clin Neurosci) - No abstract available

Journal • Autism Spectrum Disorder • Genetic Disorders

Population pharmacokinetic and pharmacodynamic model guided weight-tiered dose of AST-001 in pediatric patients with autism spectrum disorder. (PubMed, Front Pharmacol) - "These doses are expected to significantly improve ASD symptoms. This study not only proposes an optimized dosing strategy for AST-001 but also provides valuable insights into the PK-PD relationship in pediatric ASD treatment."

Journal • PK/PD data • Autism Spectrum Disorder • Genetic Disorders • Pediatrics

Examining the feasibility and limitations of AST-001 as a treatment for autism spectrum disorder. (PubMed, Psychiatry Clin Neurosci) - No abstract available

Journal • Autism Spectrum Disorder • Genetic Disorders

AST-001 versus placebo for social communication in children with autism spectrum disorder: A randomized clinical trial. (PubMed, Psychiatry Clin Neurosci) - "Our results provide preliminary evidence for the efficacy of AST-001 for the core symptoms of ASD."

Clinical • Journal • Autism Spectrum Disorder • Genetic Disorders

Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Astrogen, Inc.

New P3 trial • Autism Spectrum Disorder • Genetic Disorders