Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Phase 3 Completed 133 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Timeline

Start: 2012-11
Primary completion: 2013-08
Completion: 2013-09

Outcome

Met primary endpoint

registry Aripiprazole Low Dose vs Placebo; p = 0.0020; Treatment difference -6.26 (95% CI -10.18 to -2.34) NCT01727700 ↗

registry Aripiprazole High Dose vs Placebo; p <0.0001; Treatment difference -9.85 (95% CI -13.84 to -5.86) NCT01727700 ↗

Publications

Sallee F, Kohegyi E, Zhao J, McQuade R, Cox K, Sanchez R, van Beek A, Nyilas M, Carson W, Kurlan R. Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 10.1089/cap.2016.0026. Epub 2017 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	5 mg	Oral
Subject	Aripiprazole	Other / unclassified	10 mg	Oral
Subject	Aripiprazole	Other / unclassified	20 mg	Oral