Phase III Study of 5LGr to Treat Tic Disorder - Full Text View

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:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:


Disease Tic Disorders Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Mental Disorders Diagnosed in Childhood Movement Disorders Nervous System Diseases Neurodegenerative Diseases Pathologic Processes	Tiapride Hydrochloride Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants Dopamine Agents Dopamine Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015