Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

• Status: Completed
• Trial end date: 2013-11-06
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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