A clinical trial to test the safety and effectiveness of aripiprazole againstplacebo in children and adolescents with Tourette's Disorder

• Conditions: Tics associated with Tourette's Disorder in children and adolescents; MedDRA version: 14.1Level: PTClassification code 10044126Term: Tourette's disorderSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-003488-23-IT
• Lead Sponsor: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-21
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. The subject is a male or female child or adolescent, 7-17 years of age
(inclusive) at the time of signing the informed consent/assent.
2. The subject meets current DSM-IV-TR diagnostic criteria for Tourette's
Disorder, as confirmed by the K-SADS-PL, including the Diagnostic
Supplement 5 (Substance Abuse and Other Diseases, ie, Tic Disorders).
3. The subject has a TTS = 20 on the YGTSS at Screening and Baseline
(randomization).
4. The subject, a caregiver, and the investigator must all agree that the
presenting tic symptoms cause impairment in the subject's normal
routines, which include academic achievement, occupational functioning,
social activities, and/or relationships.
5. Females of childbearing potential (defined by menarche and not
having undergone surgical sterilization/hysterectomy) must have a
negative pregnancy test, must be practicing acceptable double-barrier
methods of contraception (or can confirm abstinence at each scheduled
visit), and must not be pregnant or lactating.6. Written informed consent must be obtained from a legally acceptable representative (eg, guardian or caregiver), in accordance with local law and the requirements of the trial center's institutional review board
(IRB) or independent ethics committee (IEC), prior to the initiation of
any protocol-required procedures. In addition, the subject, as required
by the trial center's IRB/IEC, must provide informed assent at Screening
and as such must be able to understand that he or she can withdraw
from the trial at any time.
7. The subject and the designated guardian(s) or caregiver(s) are able to
comprehend and satisfactorily comply with the protocol requirements, as
evaluated by the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 126
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject presents with a clinical presentation and/or history that isconsistent with another neurologic condition that may have accompanying abnormal movements.
2. The subject has a history of schizophrenia, bipolar disorder, or other psychotic disorder.
3. Subjects who receive psychostimulants for the treatment of ADD/ADHD and who have developed and/or had exacerbations of the tic disorder after the initiation of stimulant treatment.
4. The subject currently meets DSM-IV-TR criteria for a primary mood disorder.
5. The subject has severe obsessive-compulsive disease (OCD), as evidenced by a Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS) score > 16.
6. The subject has taken aripiprazole within 1 month (30 days) of the Screening visit.
7. Subjects who received any investigational agent in a clinical trial within 30 days prior to Screening; or who were previously enrolled in Studies 31-10-272, 31-10-273, or 31-10-274; or who were randomized into a clinical trial with once-daily aripiprazole at any time.
8. The subject has a history of neuroleptic malignant syndrome.
9. Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 days following the last dose of study drug, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 30 days following the last dose of study drug. Abstinence will be permitted if it is confirmed and documented at every trial visit.
10. Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving trial drug.
11. The subject represents a significant risk of committing suicide basedon history routine psychiatric status examination, investigator's judgment, or who have an answer of yes on any question other than 1-3 (current or over the last 30 days) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
12. Body weight is lower than 16 kg.
13. Subjects who have taken neuroleptic or antiparkinson drugs less than 14 days prior to randomization.
14. Subjects requiring cognitive-behavioral therapy (CBT) for Tourette's Disorder during the trial period. CBT for other nonexclusionary disorders must remain consistent throughout the trial.
15. The subject has met DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
16. A positive drug screen for cocaine, alcohol, or other drugs of abuse
17. Subject requiring medication not allowed per protocol.
18. Use of any Cytochrome P450 (CYP)2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for the 14 days prior to dosing and for the duration of the trial.
19. 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.
20. The inability to swallow tablets or tolerate oral medication.
21. The following laboratory test results, vital sign, measurements, and electrocardiogram (ECG) results are exclusionary: 1) Platelets = 75,000/mm3 2) Hemoglobin = 9 g/dL 3) Neutrophils, absolute = 1000/mm3 4) Aspartate aminotransferase (AST) > 3x ULN as defined by the central laboratory 5) Alanine aminotransferase (ALT) > 3x ULN as defined by the central laboratory 6) Creatinine = 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of aripiprazole with placebo in the suppression<br>of tics in children and adolescents (7-17 years) with a diagnosis of<br>Tourette's Disorder.;Secondary Objective: To evaluate the safety and tolerability of aripiprazole once-daily<br>treatment with oral tablets in children and adolescents with a diagnosis<br>of Tourette's Disorder;Primary end point(s): Change from baseline to endpoint on the Total Tic Score (TTS) of the<br>Yale Global Tic Severity Scale (YGTSS).;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS)<br>change score at endpoint (change score obtained from CGI-TS<br>improvement scale assessment).;Timepoint(s) of evaluation of this end point: 8 weeks