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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Matching Placebo Once-Daily
干预措施: Placebo (Drug)
Aripiprazole 5 mg or 10 mg
Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily
干预措施: Aripiprazole (Drug)
Aripiprazole 10 mg or 20 mg
Aripiprazole 10 mg 20 mg Immediate Release Once-Daily
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
时间窗: 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.
次要结局
- 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)