A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Flexible-Dose Once-weekly 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
- 135
- 主要终点
- Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)
研究概览
简要总结
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.
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
- •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.
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.
- •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 >
- •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
研究组 & 干预措施
Aripiprazole
Aripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
干预措施: Aripiprazole (Drug)
Placebo
Participants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline 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 the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were 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. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed.
次要结局
- Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score(Baseline to Week 8)
- Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score(Baseline to Week 8)