Phase III Study of 5LGr to Treat Tic Disorder

NCT01501695 | Completed Phase 3 DMC

• 1 other identifier: NCT00797953
• Study Type: interventional
• Target: 603
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tic Disorder; Tourette Syndrome; Chronic Tic Disorder

Keywords

tic disorder; pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 8 weeks of completion intervention.

Secondary Outcomes (3)

• Change of syndrome scales from baseline at 8 weeks;

  Within 8 weeks of completion intervention.

• Change of YGTSS scores from baseline at 2 weeks;

  within 2 weeks of intervention

• Change of syndrome scales from baseline at 2 weeks;

  Within 2 weeks of intervention

Study Arms (3)

5LGr, granule and placebo tablet

EXPERIMENTAL

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

tiapride tabletand mimic 5LGr granule

ACTIVE COMPARATOR

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

placebo, granule and tablet

PLACEBO COMPARATOR

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

Interventions

5LGr DRUG

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.

Also known as: Wuling Granule

5LGr, granule and placebo tablet

tiapride DRUG

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.

Also known as: Tiapridel, Tiapridax

tiapride tabletand mimic 5LGr granule

placebo DRUG

mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Also known as: Blank tablet

placebo, granule and tablet

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>1 year history of diagnosed tic disorder;
• age:5-18 yrs;
• YGTSS score\>=30 at baseline.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead

Related Publications (1)

• 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.

  PMID: 26072932 DERIVED

Related Links

• Manufacturer

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Interventions

Tiapride Hydrochloride

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• 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.

  Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Yuyan Chen, M.D.

  Zhejiang University of TCM affiliated hospital

  PRINCIPAL INVESTIGATOR

• Ying Ding, M.D.

  Henan University of TCM affiliated hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: October 1, 2011
• Last Updated: December 12, 2012

Record last verified: 2012-12