ML-004-002 is a Phase 2, multi-center, randomized, double-blind, placebo- controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective of the study will be to evaluate the efficacy of ML-004 compared with placebo for the treatment of care/study partner-reported social communication deficits in patients with ASD.~Subjects will be randomized to study treatment in a 1:1 ratio of ML-004: placebo.~Treatment will begin with 2 weeks of once daily dosing of ML-004 or placebo followed by a 9-12 day dose-titration phase until the maximum allowable tolerated dose (based on subject weight) is reached. The maximum dose tolerated during dose titration will become the maintenance dose (MD) for that subject, and the subject will remain on this dose for 12 weeks, followed by a down titration. An independent DSMC will monitor trial progress and ensure that the safety of trial subjects is not compromised.
ML-004-002 is a multi-center, randomized, double-blind, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD