Status:
COMPLETED
Phase III Study of 5LGr to Treat Tic Disorder
Lead Sponsor:
Tasly Pharmaceuticals, Inc.
Conditions:
Tic Disorder
Tourette Syndrome
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- \>1 year history of diagnosed tic disorder;
- age:5-18 yrs;
- YGTSS score\>=30 at baseline.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT01501695
Start Date
January 1 2008
End Date
October 1 2011
Last Update
December 12 2012
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