PHARM - MapLight Study - Open-Label Extension

2025

ML-004-003 is a Phase 2, multi-center, open-label extension study to assess the safety and tolerability of ML-004 in subjects with ASD who completed the antecedent Phase 2, double-blind, placebo-controlled, study ML-004-002. All subjects who completed study ML-004-002 will have the option to enter the extension study. This study will enroll approximately 120 adolescents and adults with ASD to investigate a new treatment for social communication difficulties. Total study duration from initiation of screening to the subject's final study visit may be up to approximately 62 weeks. Participants can withdraw at any time.

Autism Spectrum Disorder; Medication Research; Social Communication

Performing Research or Evaluation

Health-Related Activities, Other

Family Members/Caregivers, Adults with Disabilities, Children/Adolescents with Disabilities/SHCN

Specific Groups

International

N/A