Phase III Study of 5LGr to Treat Tic Disorder

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.

Detailed Description
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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.

Official Title
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A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder

Conditions
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Tic Disorder, Tourette Syndrome, Chronic Tic Disorder

Intervention / Treatment
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* Drug: 5LGr
* Drug: tiapride
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5LGr, granule and placebo tablet<br>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. | Drug: 5LGr<br>* Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.<br>* Other names: Wuling Granule;|
| Active Comparator: tiapride tabletand mimic 5LGr granule<br>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. | Drug: tiapride<br>* dosage form: tablet Strength:100 mg Dosage: 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. Total duration:8 weeks.<br>* Other names: Tiapridel, Tiapridax;|
| Placebo Comparator: placebo, granule and tablet<br>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. | Drug: placebo<br>* mimetic granule: same with 5LGr mimetic tablet: same with tiapride<br>* Other names: Blank tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks | 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. | Within 8 weeks of completion intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of syndrome scales from baseline at 8 weeks; |  | Within 8 weeks of completion intervention. | 
| Change of YGTSS scores from baseline at 2 weeks; |  | within 2 weeks of intervention | 
| Change of syndrome scales from baseline at 2 weeks; |  | Within 2 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tic disorder, pediatric