Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Last updated: February 12, 2015
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Autism

Tic Disorders

Treatment

N/A

Clinical Study ID

NCT01727700
31-12-293
  • Ages 7-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female, 7 to 17 year old (inclusive) at the time of signing consent

  • meets DSM-IV-TR diagnostic criteria for Tourette's Disorder

  • Presenting tic symptoms cause impairment in the subject's normal routines, whichinclude academic achievement, occupational functioning, social activities, and/orrelationships

  • Females of childbearing potential must have a negative pregnancy test, must bepracticing acceptable double-barrier methods of contraception and must not be pregnantor lactating

  • Written informed consent obtained from a legally acceptable representative & informedassent at Screening as applicable by trial center's IRB/IEC

  • The subject, designated guardian(s) or caregiver(s) are able to comprehend andsatisfactorily comply with the protocol requirements, as evaluated by the investigator

Exclusion

Exclusion Criteria:

  • Clinical presentation and/or history, consistent with another neurologic conditionthat 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 developedand/or had exacerbations of tic disorder after initiation of stimulant treatment

  • Currently meets DSM-IV-TR criteria for a primary mood disorder

  • Severe Obsessive Compulsive Disorder (OCD)

  • Taken aripiprazole within 30 days of the Screening visit

  • Received any investigational agent in a clinical trial within 30 days prior toScreening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomizedinto a clinical trial with Once-daily aripiprazole at any time

  • History of neuroleptic malignant syndrome

  • Sexually active patients not using 2 approved methods of contraception

  • Females breastfeeding or pregnant (positive blood pregnancy test prior to receivingtrial drug)

  • Risk of committing suicide

  • Body weight lower than 16 kg

  • Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization

  • Requiring cognitive behavioral therapy (CBT) for Tourette's during trial

  • Subject meets DSM-IV-TR criteria for any significant psychoactive substance usedisorder 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 dosingand for duration of trial

  • Use of herbal medications of any kind and nutritional or dietary supplements forTourette's disorder within 7 days prior to dosing and for the duration of the trial

  • Inability to swallow tablets or tolerate oral medication

  • Abnormal laboratory test results, vital signs and ECG results

Study Design

Total Participants: 133
Study Start date:
November 01, 2012
Estimated Completion Date:
September 30, 2013

Study 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 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 has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. 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.

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    Quilmes,
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    Gent,
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    Ruse,
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