A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 603
- 主要终点
- Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.
详细描述
5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM theory.The aim of this study is prove the effective and safety of 5LGr in children and adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>1 year history of diagnosed tic disorder;
- •age:5-18 yrs;
- •YGTSS score>=30 at baseline.
排除标准
- •Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.
- •Any indefinite tic disorder or tic disorders caused by medication.
- •Participation to other studies.
- •Patients with loose stool.
研究组 & 干预措施
5LGr, granule and placebo tablet
Drug:5LGr; Dosage form:Granule;Strength:5 gram/sack;Mimic Tablet:0 mg/tablet. Dosage: 5LGr Granule: 1 sack, t.i.d. for patients less than 12 yrs,whereas 1.5 sacks, t.i.d. for patients 13-18 yrs.
Mimic tablet:For patients 5-12 yrs: 0.5 tablet, b.i.d for first 2 weeks, then 1 tablet, bid for next 6 weeks; for patients 13-18 yrs: tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks.
Duration: 8 weeks.
干预措施: 5LGr (Drug)
tiapride tabletand mimic 5LGr granule
Tiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo.
Dosage: Tiaptride tablet: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.
Mimic 5LGr Granule:Strength:0 gram/sack.Dosage:1 sack for patients less than 12 yrs,while 1.5 sacks for patients 13-18 yrs.Frequency: T.i.d.
Duration: 8 weeks.
干预措施: tiapride (Drug)
placebo, granule and tablet
This arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients.
Dosage form: Mimic Granule:Strength:0 gram/sack Dosage:1 sack, t.i.d for patients less than 12 yrs,while 1.5 sacks, t.i.d for patients 13-18 yrs.
Mimic tablet:Strength:0 mg/tablet.For patients 5-12 yrs: 0.5 tablets b.i.d for first 2 weeks, then 1 tablet,b.i.d for next 6 weeks; for patients 13-18 yrs:1 tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks.
Duration: 8 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
时间窗: Within 8 weeks of completion intervention.
The outcome will be assessed at 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks.
次要结局
- Change of YGTSS scores from baseline at 2 weeks;(within 2 weeks of intervention)
- Change of syndrome scales from baseline at 8 weeks;(Within 8 weeks of completion intervention.)
- Change of syndrome scales from baseline at 2 weeks;(Within 2 weeks of intervention)