NCT05081245

ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

A Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: MapLight Therapeutics · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits 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.
DRUG	ML-004 Placebo	Participants will receive matching placebo once daily.

Timeline

• Start date: 2022-09-13
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2021-10-18
• Last updated: 2025-12-22

Locations

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

Regulatory

• FDA-regulated drug study