drugset / Trial / NCT01911442

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Lurasidone Small molecule 20 mg
Subject Lurasidone Small molecule 60 mg

Indications