Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Inclusion Criteria:

- 7 to 17 year old with DSM-IV-TR diagnostic criteria for TD, confirmed by the
K-SADS-PL, including the Diagnostic Supplement 5

- Has a TTS ≥ 20 on the YGTSS at Screening and Baseline

- 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 ICF 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 OCD, per CY-BOCS score > 16.

- Taken aripiprazole within 30 days of the Screening visit.

- Received any investigational agent in a clinical trial within 30 days prior to
Screening or who were randomized into a clinical trial with Once-weekly aripiprazole
at any time.

- History of neuroleptic malignant syndrome.

- Sexually active patients not using 2 approved methods of contraception; breastfeeding
or pregnant.

- Risk of committing suicide

- Body weight lower than 16 kg

- Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization.

- Requiring CBT for TD 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

- Inability to swallow tablets or tolerate oral medication

- Abnormal laboratory test results, vital signs and ECG results