<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01727700</url>
  </required_header>
  <id_info>
    <org_study_id>31-12-293</org_study_id>
    <nct_id>NCT01727700</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole&#xD;
      in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance&#xD;
      of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent,&#xD;
      non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of&#xD;
      medications approved for the treatment of Tourette's Disorder. The goal of the current trial&#xD;
      is to obtain efficacy, safety, and tolerability data in a controlled condition of a&#xD;
      Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The&#xD;
      trial has an 8-week long double-blind treatment period after a pretreatment&#xD;
      (screening/washout phase), and the subjects will be followed up for 1 month after the last&#xD;
      treatment. The Once-daily tablet formulation that will be evaluated in this trial represents&#xD;
      a daily dosage regimen that is intended to be administered to children and adolescents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.</measure>
    <time_frame>Week 8</time_frame>
    <description>To assess CGI-TS severity, the rater or physician answered the following question: &quot;Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?&quot; However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>Week 8</time_frame>
    <description>Clinical response is defined as &gt; 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Discontinuation Rate</measure>
    <time_frame>Week 8</time_frame>
    <description>Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Tourette's Disorder</condition>
  <condition>Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching Placebo Once-Daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aripiprazole 5 mg or 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aripiprazole 10 mg or 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aripiprazole 10 mg 20 mg Immediate Release Once-Daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole</intervention_name>
    <description>Once-daily, tablet</description>
    <arm_group_label>Aripiprazole 10 mg or 20 mg</arm_group_label>
    <arm_group_label>Aripiprazole 5 mg or 10 mg</arm_group_label>
    <other_name>Abilify</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female, 7 to 17 year old (inclusive) at the time of signing consent&#xD;
&#xD;
          -  meets DSM-IV-TR diagnostic criteria for Tourette's Disorder&#xD;
&#xD;
          -  Presenting tic symptoms cause impairment in the subject's normal routines, which&#xD;
             include academic achievement, occupational functioning, social activities, and/or&#xD;
             relationships&#xD;
&#xD;
          -  Females of childbearing potential must have a negative pregnancy test, must be&#xD;
             practicing acceptable double-barrier methods of contraception and must not be pregnant&#xD;
             or lactating&#xD;
&#xD;
          -  Written informed consent obtained from a legally acceptable representative &amp; informed&#xD;
             assent at Screening as applicable by trial center's IRB/IEC&#xD;
&#xD;
          -  The subject, designated guardian(s) or caregiver(s) are able to comprehend and&#xD;
             satisfactorily comply with the protocol requirements, as evaluated by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical presentation and/or history, consistent with another neurologic condition&#xD;
             that may have accompanying abnormal movements&#xD;
&#xD;
          -  History of schizophrenia, bipolar disorder, or other psychotic disorder&#xD;
&#xD;
          -  Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed&#xD;
             and/or had exacerbations of tic disorder after initiation of stimulant treatment&#xD;
&#xD;
          -  Currently meets DSM-IV-TR criteria for a primary mood disorder&#xD;
&#xD;
          -  Severe Obsessive Compulsive Disorder (OCD)&#xD;
&#xD;
          -  Taken aripiprazole within 30 days of the Screening visit&#xD;
&#xD;
          -  Received any investigational agent in a clinical trial within 30 days prior to&#xD;
             Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized&#xD;
             into a clinical trial with Once-daily aripiprazole at any time&#xD;
&#xD;
          -  History of neuroleptic malignant syndrome&#xD;
&#xD;
          -  Sexually active patients not using 2 approved methods of contraception&#xD;
&#xD;
          -  Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving&#xD;
             trial drug)&#xD;
&#xD;
          -  Risk of committing suicide&#xD;
&#xD;
          -  Body weight lower than 16 kg&#xD;
&#xD;
          -  Taken neuroleptic or antiparkinson drugs &lt; 14 days prior to randomization&#xD;
&#xD;
          -  Requiring cognitive behavioral therapy (CBT) for Tourette's during trial&#xD;
&#xD;
          -  Subject meets DSM-IV-TR criteria for any significant psychoactive substance use&#xD;
             disorder within the past 3 months&#xD;
&#xD;
          -  Positive drug screen&#xD;
&#xD;
          -  Subject requires medications not allowed per protocol&#xD;
&#xD;
          -  Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing&#xD;
             and for duration of trial&#xD;
&#xD;
          -  Use of herbal medications of any kind and nutritional or dietary supplements for&#xD;
             Tourette's disorder within 7 days prior to dosing and for the duration of the trial&#xD;
&#xD;
          -  Inability to swallow tablets or tolerate oral medication&#xD;
&#xD;
          -  Abnormal laboratory test results, vital signs and ECG results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Kohegyi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corona</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gainsville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Petersburg</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
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    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
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    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
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      <address>
        <city>Bloomfield Hills</city>
        <state>Michigan</state>
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        <state>New Jersey</state>
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        <state>New York</state>
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        <state>New York</state>
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        <state>New York</state>
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        <state>North Carolina</state>
        <country>United States</country>
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        <state>Ohio</state>
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        <state>Ohio</state>
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        <state>Oklahoma</state>
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        <state>Oregon</state>
        <country>United States</country>
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        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
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        <city>Mt. Pleasant</city>
        <state>South Carolina</state>
        <country>United States</country>
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        <state>Tennessee</state>
        <country>United States</country>
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        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
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        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
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        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
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      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
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      <address>
        <city>Orem</city>
        <state>Utah</state>
        <country>United States</country>
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        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
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      <address>
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        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
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      <address>
        <city>Henrico</city>
        <state>Virginia</state>
        <country>United States</country>
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        <state>Virginia</state>
        <country>United States</country>
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      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Bothell</city>
        <state>Washington</state>
        <country>United States</country>
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      <address>
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        <state>Wisconsin</state>
        <country>United States</country>
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      <address>
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        <state>Nova Scotia</state>
        <country>Canada</country>
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    <facility>
      <address>
        <city>Parry Sound</city>
        <state>Ontario</state>
        <country>Canada</country>
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    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Whitby</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
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      <address>
        <city>Dresden</city>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Wurzburg</city>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durango</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leon</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Finland</country>
    <country>Netherlands</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <results_first_submitted>January 9, 2015</results_first_submitted>
  <results_first_submitted_qc>February 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 13, 2015</results_first_posted>
  <disposition_first_submitted>July 28, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>July 28, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 1, 2014</disposition_first_posted>
  <last_update_submitted>February 12, 2015</last_update_submitted>
  <last_update_submitted_qc>February 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tourette Syndrome</keyword>
  <keyword>Basal Ganglia Diseases</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Tic Disorders</keyword>
  <keyword>Tics</keyword>
  <keyword>Movement Disorders</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Aripiprazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tourette Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial in children and adolescents (aged 7-17 years) with Tourette's disorder (TD). 171 participants were screened, of which 133 were randomized to treatment.</recruitment_details>
      <pre_assignment_details>The trial consisted of a pretreatment phase and a treatment phase. Pretreatment phase consisted of a screening and washout (when applicable) period. This was followed by an 8-week treatment phase starting with the baseline visit (Day 0). Particpants were randomized 1:1:1 to aripiprazole high dose, aripiprazole low dose or placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Aripiprazole Low Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="P2">
          <title>Aripiprazole High Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Particpant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Aripiprazole Low Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="B2">
          <title>Aripiprazole High Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="44"/>
            <count group_id="B4" value="133"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="3.1"/>
                    <measurement group_id="B2" value="11.8" spread="2.8"/>
                    <measurement group_id="B3" value="11.6" spread="2.8"/>
                    <measurement group_id="B4" value="11.5" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).</title>
        <description>The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).</title>
          <description>The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.</description>
          <population>Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.35" spread="1.59"/>
                    <measurement group_id="O2" value="-16.94" spread="1.61"/>
                    <measurement group_id="O3" value="-7.09" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation [SD] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0020</p_value>
            <p_value_desc>The Hochberg procedure was used to adjust for multiplicity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</method_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-6.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.18</ci_lower_limit>
            <ci_upper_limit>-2.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The Hochberg procedure was used to adjust for multiplicity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</method_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-9.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.84</ci_lower_limit>
            <ci_upper_limit>-5.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.</title>
        <description>To assess CGI-TS severity, the rater or physician answered the following question: &quot;Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?&quot; However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.</title>
          <description>To assess CGI-TS severity, the rater or physician answered the following question: &quot;Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?&quot; However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.</description>
          <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="0.21"/>
                    <measurement group_id="O2" value="2.13" spread="0.21"/>
                    <measurement group_id="O3" value="3.15" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <p_value_desc>The Hochberg procedure was used to adjust for multiplicity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</method_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.54</ci_lower_limit>
            <ci_upper_limit>-0.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>The Hochberg procedure was used to adjust for multiplicity.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</method_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.54</ci_lower_limit>
            <ci_upper_limit>-0.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score</title>
        <description>The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score</title>
          <description>The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.</description>
          <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.69" spread="3.34"/>
                    <measurement group_id="O2" value="-32.80" spread="3.39"/>
                    <measurement group_id="O3" value="-13.43" spread="3.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0017</p_value>
            <p_value_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-13.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.43</ci_lower_limit>
            <ci_upper_limit>-5.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-19.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.70</ci_lower_limit>
            <ci_upper_limit>-11.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score</title>
        <description>The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score</title>
          <description>The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.</description>
          <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" spread="0.19"/>
                    <measurement group_id="O2" value="-1.47" spread="0.19"/>
                    <measurement group_id="O3" value="-0.55" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0010</p_value>
            <p_value_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Treatment difference</param_type>
            <param_value>-0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>-0.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>MMRM</param_type>
            <param_value>-0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.41</ci_lower_limit>
            <ci_upper_limit>-0.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate</title>
        <description>Clinical response is defined as &gt; 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>Clinical response is defined as &gt; 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.</description>
          <population>ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.</population>
          <units>Percentage of Responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8"/>
                    <measurement group_id="O2" value="88.6"/>
                    <measurement group_id="O3" value="54.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0835</p_value>
            <p_value_desc>P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Response ratio &gt; 1 favors aripiprazole.</method_desc>
            <param_type>Response ratio</param_type>
            <param_value>1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0014</p_value>
            <p_value_desc>P-value derived from CMH General Association Test adjusting for region and weight group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Response ratio &gt; 1 favors aripiprazole.</method_desc>
            <param_type>Response ratio</param_type>
            <param_value>1.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.20</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Discontinuation Rate</title>
        <description>Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT Population: All participants randomly assigned to the double-blind treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Aripiprazole Low Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O2">
            <title>Aripiprazole High Dose</title>
            <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Discontinuation Rate</title>
          <description>Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.</description>
          <population>ITT Population: All participants randomly assigned to the double-blind treatment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="22.5"/>
                    <measurement group_id="O3" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9187</p_value>
            <p_value_desc>Discontinuation ratio &lt; 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Discontinuation ratio</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>7.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9576</p_value>
            <p_value_desc>Hazard ratio &lt; 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0132</p_value>
            <p_value_desc>Discontinuation ratio &lt; 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Discontinuation ratio</param_type>
            <param_value>4.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.10</ci_lower_limit>
            <ci_upper_limit>14.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0278</p_value>
            <p_value_desc>Hazard ratio &lt; 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.</p_value_desc>
            <method>Regression, Cox</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>5.51</param_value>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were recorded from the time of signing the informed consent up to 30 days after the last trial visit.</time_frame>
      <desc>An AE is defined as any untoward medical occurrence with the use of study drug. AE was considered serious if fatal, life threatening, disabling or incapacitating, required in participant hospitalization or prolonged hospitalization, congenital anomaly/birth defect or other medically significant event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Aripiprazole Low Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="E2">
          <title>Aripiprazole High Dose</title>
          <description>For participants who weighed &lt; 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets in the same way as aripiprazole.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Affairs</name_or_title>
      <organization>Otsuka Pharmaceutical Development and Commercialization, Inc.</organization>
      <phone>800 562-3974</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01727700
org study id: 31-12-293
nct id: NCT01727700
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
time frame: Baseline to Week 8
description: The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.
measure: Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.
time frame: Week 8
description: To assess CGI-TS severity, the rater or physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
measure: Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score
time frame: Baseline to Week 8
description: The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.
measure: Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score
time frame: Baseline to Week 8
description: The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.
measure: Response Rate
time frame: Week 8
description: Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.
measure: Treatment Discontinuation Rate
time frame: Week 8
description: Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching Placebo Once-Daily
arm group label: Aripiprazole 5 mg or 10 mg
arm group type: Experimental
description: Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily
arm group label: Aripiprazole 10 mg or 20 mg
arm group type: Experimental
description: Aripiprazole 10 mg 20 mg Immediate Release Once-Daily
intervention type: Drug
intervention name: Aripiprazole
description: Once-daily, tablet
arm group label: Aripiprazole 10 mg or 20 mg
arm group label: Aripiprazole 5 mg or 10 mg
other name: Abilify
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Eva Kohegyi, MD
role: Study Director
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
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country: Canada
country: Germany
country: Hungary
country: Italy
country: Mexico
country: Romania
country: Spain
country: Sweden
country: United States
country: Argentina
country: Belgium
country: Bulgaria
country: Finland
country: Netherlands
country: Peru
country: Poland
country: United Kingdom
responsible party type: Sponsor
mesh term: Tic Disorders
mesh term: Tics
mesh term: Tourette Syndrome
mesh term: Aripiprazole
participant flow: 
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reported events: 
certain agreements: 
point of contact: 