NCT01911442

Lurasidone Pediatric Autism Study

A 6-Week, Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Irritability Associated With Autistic Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Autism

Interventions

Type	Name	Description
DRUG	Lurasidone 20 mg daily	Lurasidone 20 mg once daily
DRUG	Lurasidone	Lurasidone 60 mg once daily
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-07-30
• Last updated: 2016-02-25
• Results posted: 2016-02-25

Locations

41 sites across 1 country: United States