Overview

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

Status:
Completed
Trial end date:
2014-03-12
Target enrollment:
0
Participant gender:
All
Summary
The goal of the current trial 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