NCT05889273

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

An Open-label Extension Study to Investigate Safety and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: MapLight Therapeutics · Industry
• Sex: All
• Age: 12 Years – 46 Years
• Healthy volunteers: Not accepted

Summary

ML-004-003 is a multi-center, open-label extension study that will enroll approximately 120 adolescent and adult subjects with ASD that have completed study ML-004-002. The primary objective of the study will be to evaluate the safety of ML-004 in subjects with ASD.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	ML-004 (IR)/(ER) tablet	Participants will receive ML-004 once daily.

Timeline

• Start date: 2023-06-01
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2023-06-05
• Last updated: 2026-03-16

Locations

21 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study