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

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Brief Title

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

Official Title

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

Brief Summary

      The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing
      Total Tic Severity in children and adolescents with Tourette's Disorder.

Detailed Description

      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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of Participants With Adverse Events.

Secondary Outcome

 Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).

Condition

Tourette's Disorder

Intervention

Aripiprazole

Study Arms / Comparison Groups

 Aripiprazole
Description:  Aripiprazole Immediate Release Once-Daily

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

110

Start Date

January 2013

Completion Date

September 2014

Primary Completion Date

August 2014

Eligibility Criteria

        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

Gender

All

Ages

7 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Eva Kohegyi, MD, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT01727713

Organization ID

31-12-294

Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Sponsor

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

Verification Date

September 2015