A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Tourette's Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Enrollment
- 133
- Primary Endpoint
- Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed Description
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.
Investigators
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)
Arms & Interventions
Placebo
Matching Placebo Once-Daily
Intervention: Placebo
Aripiprazole 5 mg or 10 mg
Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily
Intervention: Aripiprazole
Aripiprazole 10 mg or 20 mg
Aripiprazole 10 mg 20 mg Immediate Release Once-Daily
Intervention: Aripiprazole
Outcomes
Primary Outcomes
Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
Time Frame: Baseline to Week 8
The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.
Secondary Outcomes
- Response Rate(Week 8)
- Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score(Baseline to Week 8)
- Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.(Week 8)
- Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score(Baseline to Week 8)
- Treatment Discontinuation Rate(Week 8)