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

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.

Timeline

Start

2022-09-13

Primary completion

2026-03-10

Completion

2026-04-17

Outcome

Missed primary endpoint

release “While the study did not meet its primary endpoint in social communication, a prespecified analysis demonstrated clinically meaningful improvements in irritability” maplightrx.com ↗

Drugs

Indications