NCT01727700

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Conditions

• Tourette's Disorder
• Tic Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Once-daily, tablet
DRUG	Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-11-16
• Last updated: 2015-02-13
• Results posted: 2015-02-13

Locations

75 sites across 9 countries: United States, Canada, Germany, Hungary, Italy, Mexico, Romania, Spain, Sweden