Clinical trial NCT01727700 (phase 3, status: completed)
Conditions: tourette's disorder, tic disorder
ICD codes: F95.2, F95.0, F95.9, F95.1, F95.8
Drugs: aripiprazole, placebo
SMILES: ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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