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

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Brief Title

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

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Brief Summary

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


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Primary efficacy measure is change from Baseline to endpoint (week 8) of the Yale Global Tic Severity Scale (YGTSS).

Secondary Outcome

 The key secondary efficacy endpoints will be the CGI-TS change score at endpoint (week 8) (change score obtained from CGI-TS improvement scale assessment) and the mean changes from Baseline to endpoint (week 8) in GTS-QOL overall score.

Condition

Tourette's Disorder

Intervention

aripiprazole 52.5 mg

Study Arms / Comparison Groups

 Matching Placebo
Description:  

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

83

Start Date

July 2011

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          -  7 to 17 year old, male or female with DSM-IV-TR diagnostic criteria for TD, confirmed
             by the KSADS-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
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Eva Kohegyi, MD, , 

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations


NCT ID

NCT01418352

Organization ID

31-10-273


Responsible Party

Sponsor

Study Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.


Study Sponsor

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


Verification Date

May 2015