Phase III Study of 5LGr to Treat Tic Disorder
Phase 3
Completed
- Conditions
- Tic DisorderTourette SyndromeChronic Tic Disorder
- Interventions
- Registration Number
- NCT01501695
- Lead Sponsor
- Tasly Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 603
Inclusion Criteria
- >1 year history of diagnosed tic disorder;
- age:5-18 yrs;
- YGTSS score>=30 at baseline.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5LGr, granule and placebo tablet 5LGr 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. placebo, granule and tablet placebo 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. tiapride tabletand mimic 5LGr granule tiapride 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.
- Primary Outcome Measures
Name Time Method Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks 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.
- Secondary Outcome Measures
Name Time Method 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