Phase III Study of 5LGr to Treat Tic Disorder

Sponsor

Tasly Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01501695

Collaborator

(none)

603

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tic Disorder Tourette Syndrome Chronic Tic Disorder	Drug: 5LGr Drug: tiapride Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

603 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 5LGr 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. Other Names: Wuling Granule
Active Comparator: 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.	Drug: tiapride 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. Other Names: Tiapridel, Tiapridax
Placebo Comparator: 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.	Drug: placebo mimetic granule: same with 5LGr mimetic tablet: same with tiapride Other Names: Blank tablet

Arm

Intervention/Treatment

Experimental: 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.

Drug: 5LGr

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.

Other Names:

Wuling Granule

Active Comparator: 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.

Drug: tiapride

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.

Other Names:

Tiapridel, Tiapridax

Placebo Comparator: 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.

Drug: placebo

mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Other Names:

Blank tablet

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tasly Pharmaceuticals, Inc.

Investigators

Principal Investigator: Xinmin Han, M.D., Nanjing University of TCM affiliated hospital
Principal Investigator: Yi zheng, Capital Medical University
Principal Investigator: Minjie Wang, M.D., Nanjing Medical college Attached Brain Branch Hospital
Principal Investigator: Xiaowei Wei, M.D., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Principal Investigator: Yan Cheng, M.D., Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Principal Investigator: Xuefeng Wang, M.D., The Affiliated Hospital of Liaoning University of TCM
Principal Investigator: Yuyan Chen, M.D., Zhejiang University of TCM affiliated hospital
Principal Investigator: Ying Ding, M.D., Henan University of TCM affiliated hospital