Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder|
- Number and percentage of subjects with adverse events [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
- Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
- Change from Baseline to endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale(YGTSS) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
- The long-term effect of Once-daily aripiprazole measured by the Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOL) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Aripiprazole Immediate Release Once-Daily
Open Label: Once-Daily formulation of aripiprazole flex dose regimine
Other Name: Abilify
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.
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|Study Director:||Eva Kohegyi, MD||Otsuka Pharmaceutical Development & Commercialization, Inc.|