Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Intervention: Aripiprazole; Placebo
Intervention description: Aripiprazole tablet administered orally once a week.; Aripiprazole-matching placebo tablet administered orally once a week.
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: 135.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tourette's Disorder; Tic disorders

Summary:

      The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole
      in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's
      Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth
             edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD),
             confirmed by the kiddie schedule for affective disorders and schizophrenia - present
             and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5

          -  Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at
             Screening and Baseline

          -  Presenting tic symptoms cause impairment in the participant'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 form (ICF) obtained from a legally acceptable representative
             & informed assent at Screening as applicable by study center's Institutional review
             board/independent ethics committee (IRB/IEC)

          -  The participant, 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.

          -  Participant receiving psychostimulants for treatment of attention-deficit
             disorder/Attention-deficit hyperactivity disorder (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), per children's yale-brown obsessive
             compulsive scale (CY-BOCS) score >16.

          -  Taken aripiprazole within 30 days of the Screening visit.

          -  Received any investigational agent in a clinical trial within 30 days prior to
             Screening or who were randomized into a clinical trial with Once-weekly aripiprazole
             at any time.

          -  History of neuroleptic malignant syndrome.

          -  Sexually active participants not using 2 approved methods of contraception;
             breastfeeding or pregnant.

          -  Risk of committing suicide

          -  Bodyweight lower than 16 kg

          -  Taken neuroleptic or antiparkinson drugs <14 days prior to randomization.

          -  Requiring cognitive-behavioral therapy (CBT) for TD during study.

          -  Participant meets DSM-IV-TR criteria for any significant psychoactive substance use
             disorder within the past 3 months.

          -  Positive drug screen

          -  Participant 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 study.

          -  Inability to swallow tablets or tolerate oral medication

          -  Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results