Phase III Study of 5LGr to Treat Tic Disorder

Tourette Syndrome Clinical Trial

— 5LGr  

Official title:

A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501695
• Other study ID #: NCT00797953
• Status: Completed
• Phase: Phase 3
• First received: December 26, 2011
• Last updated: December 10, 2012
• Start date: January 2008
• Est. completion date: October 2011

Study information

• Verified date: December 2012
• Source: Tasly Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: October 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Disease
• Tic Disorder
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

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.
• 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.
• placebo
mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of syndrome scales from baseline at 8 weeks;		Within 8 weeks of completion intervention.
Secondary	Change of YGTSS scores from baseline at 2 weeks;		within 2 weeks of intervention
Secondary	Change of syndrome scales from baseline at 2 weeks;		Within 2 weeks of intervention

External Links

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