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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:7 - 18
Updated:1/1/2014
Start Date:August 2011
End Date:July 2015
Contact:CenterWatch
Email:tourettes@centerwatch.com

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An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

The goal of the current trial is to obtain long term efficacy, safety and tolerability data
of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.


Inclusion Criteria:

- Completed participation or discontinued due to lack of efficacy at week 5 or later in
either Trial 31-10-272 or 31-10-273

- 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:

- The subject experienced AEs during the double-blind trial (31-10-272 or 31-10-273)
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 at baseline for cocaine, alcohol or other drugs of abuse which
will result in early termination at Week 1

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

- Risk of committing suicide

- Body weight lower than 16 kg

- Abnormal laboratory test results, vital signs and ECG results
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