Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

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

The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

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 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 has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. 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.

Inclusion Criteria:

• male or female, 7 to 17 year old (inclusive) at the time of signing consent
• meets DSM-IV-TR diagnostic criteria for Tourette's Disorder
• Presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
• Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating
• Written informed consent obtained from a legally acceptable representative & informed assent at Screening as applicable by trial center's IRB/IEC
• The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator

Exclusion Criteria:

• Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements
• History of schizophrenia, bipolar disorder, or other psychotic disorder
• Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment
• Currently meets DSM-IV-TR criteria for a primary mood disorder
• Severe Obsessive Compulsive Disorder (OCD)
• Taken aripiprazole within 30 days of the Screening visit
• Received any investigational agent in a clinical trial within 30 days prior to Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with Once-daily aripiprazole at any time
• History of neuroleptic malignant syndrome
• Sexually active patients not using 2 approved methods of contraception
• Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
• Risk of committing suicide
• Body weight lower than 16 kg
• Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization
• Requiring cognitive behavioral therapy (CBT) for Tourette's during trial
• Subject meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months
• Positive drug screen
• Subject requires medications not allowed per protocol
• Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of trial
• Use of herbal medications of any kind and nutritional or dietary supplements for Tourette's disorder within 7 days prior to dosing and for the duration of the trial
• Inability to swallow tablets or tolerate oral medication
• Abnormal laboratory test results, vital signs and ECG results