Phase III Study of 5LGr to Treat Tic Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01501695
First received: December 26, 2011
Last updated: December 10, 2012
Last verified: December 2012

December 26, 2011
December 10, 2012
January 2008
November 2010   (final data collection date for primary outcome measure)
Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks [ Time Frame: Within 8 weeks of completion intervention. ] [ Designated as safety issue: No ]
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.
YGTSS score change from baseline at 8 weeks [ Time Frame: Within 8 weeks of completion intervention. ] [ Designated as safety issue: No ]
The outcome will be assessed at 2rd and 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks.
Complete list of historical versions of study NCT01501695 on ClinicalTrials.gov Archive Site
  • Change of syndrome scales from baseline at 8 weeks; [ Time Frame: Within 8 weeks of completion intervention. ] [ Designated as safety issue: No ]
  • Change of YGTSS scores from baseline at 2 weeks; [ Time Frame: within 2 weeks of intervention ] [ Designated as safety issue: No ]
  • Change of syndrome scales from baseline at 2 weeks; [ Time Frame: Within 2 weeks of intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase III Study of 5LGr to Treat Tic Disorder
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tic Disorder
  • Tourette Syndrome
  • Chronic Tic Disorder
  • 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 Name: Wuling Granule
  • 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 Name: Tiapridel, Tiapridax
  • Drug: placebo
    mimetic granule: same with 5LGr mimetic tablet: same with tiapride
    Other Name: Blank tablet
  • 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.

    Intervention: Drug: 5LGr
  • 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.

    Intervention: Drug: tiapride
  • 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.

    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
October 2011
November 2010   (final data collection date for primary outcome measure)

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.
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01501695
NCT00797953
Yes
Tasly Pharmaceuticals, Inc.
Tasly Pharmaceuticals, Inc.
Not Provided
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
Tasly Pharmaceuticals, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP