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

-
Investigator: R. Keith McBurnett, PhD
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Location(s): United States

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 additional 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 is a 52-week extension to the double-blind trial.

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