Safety and Tolerability of 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 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.

Inclusion Criteria:

- Completed participation in Trial 31-12-293

- Written ICF obtained from a legally acceptable representative & informed assent at
Baseline 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:

- Experienced AEs during the double-blind trial (31-12-293) that would, in the
investigator's judgment, preclude further exposure to aripiprazole.

- The subject had protocol violations during the double-blind trial considered major in
the judgment of the investigator which would deem the subject a poor candidate for
the trial

- A positive drug screen

- 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

- Abnormal laboratory test results, vital signs and ECG results