Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 13 Jul 2026

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At a glance

Drugs Lumateperone (Primary)
Indications Autism spectrum disorder; Pervasive child development disorders; Schizophrenia
Focus Therapeutic Use
Sponsors Intra-Cellular Therapies

07 Jul 2026 Planned number of patients changed from 174 to 160.
07 Jul 2026 Planned End Date changed from 1 Apr 2027 to 19 Jul 2027.
07 Jul 2026 Planned primary completion date changed from 1 Mar 2027 to 21 Jun 2027.

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