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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
History of Changes
  Purpose

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


Condition Intervention Phase
Tic Disorder
Tourette Syndrome
Chronic Tic Disorder
 Drug: 5LGr
Drug: tiapride
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tasly Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 603
Study Start Date: January 2008
Study Completion Date: October 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Manufacturer  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01501695     History of Changes
Other Study ID Numbers: NCT00797953
Study First Received: December 26, 2011
Last Updated: December 10, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Tic Disorders
Tics
Tourette Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
 Genetic Diseases, Inborn
Tiapride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on June 17, 2013