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

Primary Purpose

Tic Disorder, Tourette Syndrome, Chronic Tic Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
5LGr
tiapride
placebo
Sponsored by
Tasly Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic Disorder focused on measuring tic disorder, pediatric

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    5LGr, granule and placebo tablet

    tiapride tabletand mimic 5LGr granule

    placebo, granule and tablet

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change of syndrome scales from baseline at 8 weeks;
    Change of YGTSS scores from baseline at 2 weeks;
    Change of syndrome scales from baseline at 2 weeks;

    Full Information

    First Posted
    December 26, 2011
    Last Updated
    December 10, 2012
    Sponsor
    Tasly Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01501695
    Brief Title
    Phase III Study of 5LGr to Treat Tic Disorder
    Acronym
    5LGr
    Official Title
    A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tasly Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tic Disorder, Tourette Syndrome, Chronic Tic Disorder
    Keywords
    tic disorder, pediatric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    603 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5LGr, granule and placebo tablet
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    tiapride tabletand mimic 5LGr granule
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    placebo, granule and tablet
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    5LGr
    Other Intervention Name(s)
    Wuling Granule
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    tiapride
    Other Intervention Name(s)
    Tiapridel, Tiapridax
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    Blank tablet
    Intervention Description
    mimetic granule: same with 5LGr mimetic tablet: same with tiapride
    Primary Outcome Measure Information:
    Title
    Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
    Description
    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.
    Time Frame
    Within 8 weeks of completion intervention.
    Secondary Outcome Measure Information:
    Title
    Change of syndrome scales from baseline at 8 weeks;
    Time Frame
    Within 8 weeks of completion intervention.
    Title
    Change of YGTSS scores from baseline at 2 weeks;
    Time Frame
    within 2 weeks of intervention
    Title
    Change of syndrome scales from baseline at 2 weeks;
    Time Frame
    Within 2 weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xinmin Han, M.D.
    Organizational Affiliation
    Nanjing University of TCM affiliated hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yi zheng
    Organizational Affiliation
    Capital Medical University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Minjie Wang, M.D.
    Organizational Affiliation
    Nanjing Medical college Attached Brain Branch Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xiaowei Wei, M.D.
    Organizational Affiliation
    First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yan Cheng, M.D.
    Organizational Affiliation
    Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xuefeng Wang, M.D.
    Organizational Affiliation
    First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Yuyan Chen, M.D.
    Organizational Affiliation
    Zhejiang University of TCM affiliated hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ying Ding, M.D.
    Organizational Affiliation
    Henan University of TCM affiliated hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26072932
    Citation
    Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.
    Results Reference
    derived
    Links:
    URL
    http://www.tasly.com
    Description
    Manufacturer

    Learn more about this trial

    Phase III Study of 5LGr to Treat Tic Disorder

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