Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole

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