NCT01501695

Phase III Study of 5LGr to Treat Tic Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: Tasly Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Tic Disorder
• Tourette Syndrome
• Chronic Tic Disorder

Interventions

Type	Name	Description
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.
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.
DRUG	placebo	mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-11-01
• Completion: 2011-10-01
• First posted: 2011-12-29
• Last updated: 2012-12-12