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

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ClinicalTrials.gov Identifier: NCT01501695
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

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 Type : Interventional  (Clinical Trial)
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 : January 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Blank tablet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of syndrome scales from baseline at 8 weeks; [ Time Frame: Within 8 weeks of completion intervention. ]
  2. Change of YGTSS scores from baseline at 2 weeks; [ Time Frame: within 2 weeks of intervention ]
  3. Change of syndrome scales from baseline at 2 weeks; [ Time Frame: Within 2 weeks of intervention ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501695


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01501695     History of Changes
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Tasly Pharmaceuticals, Inc.:
tic disorder
pediatric

Additional relevant MeSH terms:
Disease
Tourette Syndrome
Tics
Tic Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Tiapride Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action