Brief Title
Phase III Study of 5LGr to Treat Tic Disorder
Official Title
A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
Secondary Outcome
Change of syndrome scales from baseline at 8 weeks;
Condition
Tic Disorder
Intervention
5LGr
Study Arms / Comparison Groups
5LGr, granule and placebo tablet
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
603
Start Date
January 2008
Completion Date
October 2011
Primary Completion Date
November 2010
Eligibility Criteria
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.
Gender
All
Ages
5 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Xinmin Han, M.D., ,
Administrative Informations
NCT ID
NCT01501695
Organization ID
NCT00797953
Responsible Party
Sponsor
Study Sponsor
Tasly Pharmaceuticals, Inc.
Study Sponsor
Xinmin Han, M.D., Principal Investigator, Nanjing University of TCM affiliated hospital
Verification Date
December 2012