Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole 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