Lurasidone Pediatric Autism Study

NCT01911442 ↗

Phase 3 Completed 150 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.

Timeline

Start: 2013-08
Primary completion: 2014-11
Completion: 2014-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Lurasidone 20 mg Once Daily vs Placebo; p = 0.5463; Mean Difference (Final Values) -1.3 (95% CI -5.6 to 3.0); Mixed Models Analysis NCT01911442 ↗

registry analysis (superiority or other test); Lurasidone 60 mg Once Daily vs Placebo; p = 0.3592; Mean Difference (Final Values) -1.9 (95% CI -6.1 to 2.2); Mixed Models Analysis NCT01911442 ↗

Publications

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	20 mg	—
Subject	Lurasidone	Small molecule	60 mg	—