Conditions: Tourette's Disorder Tic Disorder
Keywords: Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders Tics Movement Disorders Mental Disorders Aripiprazole
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 110
Healthy volunteers: no

Brief summary:
The goal of the current trial is to determine 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 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.

Arms:
arm 1: Aripiprazole Immediate Release Once-Daily

Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Open Label: Once-Daily formulation of aripiprazole flex dose regimine

Protocol document: