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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

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 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Tasly Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01501695
• First Posted: December 29, 2011
• Last Update Posted: December 12, 2012
• Last Verified: December 2012

Keywords provided by Tasly Pharmaceuticals, Inc.:

tic disorder; pediatric

Additional relevant MeSH terms:

Tourette Syndrome; Tics; Tic Disorders; Disease; 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