Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder; Tic Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Intervention: Aripiprazole; Placebo
Intervention description: Once-daily, tablet
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tourette Syndrome; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Tics; Movement Disorders; Mental Disorders; Aripiprazole

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 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, which
             include academic achievement, occupational functioning, social activities, and/or
             relationships

          -  Females of childbearing potential must have a negative pregnancy test, must be
             practicing acceptable double-barrier methods of contraception and must not be pregnant
             or lactating

          -  Written informed consent obtained from a legally acceptable representative & informed
             assent at Screening as applicable by trial center's IRB/IEC

          -  The subject, designated guardian(s) or caregiver(s) are able to comprehend and
             satisfactorily comply with the protocol requirements, as evaluated by the investigator

        Exclusion Criteria:

          -  Clinical presentation and/or history, consistent with another neurologic condition
             that may have accompanying abnormal movements

          -  History of schizophrenia, bipolar disorder, or other psychotic disorder

          -  Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed
             and/or had exacerbations of tic disorder after initiation of stimulant treatment

          -  Currently meets DSM-IV-TR criteria for a primary mood disorder

          -  Severe 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 to
             Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized
             into 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 receiving
             trial 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 use
             disorder within the past 3 months

          -  Positive drug screen

          -  Subject requires medications not allowed per protocol

          -  Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing
             and for duration of trial

          -  Use of herbal medications of any kind and nutritional or dietary supplements for
             Tourette'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