Phase III Study of 5LGr to Treat Tic Disorder (5LGr)

December 10, 2012 updated by: Tasly Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

603

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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., First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: Yuyan Chen, M.D., Zhejiang University of TCM affiliated hospital
  • Principal Investigator: Ying Ding, M.D., Henan University of TCM affiliated hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00797953

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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