Guanfacine in Children With Tic Disorders: A Multi-site Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).
详细描述
Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.
This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.
- •Between ages 6 yrs 0 mos and 17 years 0 months.
- •Weight >/= 15 kg (33 lbs).
- •Ability to swallow pills whole.
排除标准
- •Positive pregnancy test.
- •Positive drug test.
- •Low blood pressure.
- •Prior history of hypersensitivity to guanfacine.
- •Prior failed treatment with an adequate trial of guanfacine in last 2 years.
- •Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy.
- •Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.
研究组 & 干预措施
Inactive placebo
干预措施: placebo (Drug)
Extended-release Guanfacine
干预措施: extended-release guanfacine (Intuniv) (Drug)
结局指标
主要结局
Yale Global Tic Severity Scale (YGTSS)
时间窗: 8 weeks
The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.
次要结局
未报告次要终点