NCT01416441

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

An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.

Conditions

• Tourette's Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Aripiprazole tablets orally once daily.

Timeline

• Start date: 2011-10-19
• Primary completion: 2014-03-13
• Completion: 2014-03-13
• First posted: 2011-08-15
• Last updated: 2021-10-07
• Results posted: 2021-10-07

Locations

80 sites across 10 countries: United States, Bulgaria, Canada, Germany, Hungary, Mexico, Romania, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study