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

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Brief Title

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

Official Title

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

Brief Summary

      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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number and percentage of subjects with adverse events

Secondary Outcome

 Change from Baseline to endpoint in YGTSS TTS

Condition

Tourette's Disorder

Intervention

aripiprazole

Study Arms / Comparison Groups

 Aripiprazole
Description:  Once-weekly tablets

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

170

Start Date

August 2011

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility Criteria

        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

Gender

All

Ages

7 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Eva Kohegyi, MD, ,

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations

NCT ID

NCT01416441

Organization ID

31-10-274

Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Sponsor

Eva Kohegyi, MD, Study Director, Otsuka Pharmaceutical Development & Commercialization, Inc.

Verification Date

March 2015