NCT01418339

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (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 study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Conditions

• Tourette's Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole tablet administered orally once a week.
DRUG	Placebo	Aripiprazole-matching placebo tablet administered orally once a week.

Timeline

• Start date: 2011-07-27
• Primary completion: 2013-11-06
• Completion: 2013-11-06
• First posted: 2011-08-17
• Last updated: 2021-10-07
• Results posted: 2021-10-07

Locations

39 sites across 6 countries: United States, Canada, Hungary, Mexico, South Korea, Taiwan

Regulatory

• FDA-regulated drug study