CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Lurasidone 20 mg daily +2 moredrug
Likely dose
Lurasidone 20 mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01911442
NCT01911442Phase 3Completed
CompareCT.gov

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

Sumitomo Pharma America, Inc.·interventional·Posted Jul 30, 2013·Updated Feb 25, 2016

In Brief

A Phase 3 clinical trial evaluating Lurasidone 20 mg daily, Lurasidone, and 1 other intervention for Autism. Completed, enrolled 150 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 30, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.9 years ago

Interventions

Lurasidone 20 mg dailydrug

Lurasidone 20 mg once daily

Lurasidonedrug

Lurasidone 60 mg once daily

Placebodrug

Placebo