Clinical trial NCT01501695: Phase III Study of 5LGr to Treat Tic Disorder
Official title: A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tic Disorder
Tourette Syndrome
Chronic Tic Disorder
Keywords: tic disorder
pediatric
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-29
Enrollment: 603
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.

Eligibility 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.

Primary outcomes:
measure: Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
timeFrame: Within 8 weeks of completion intervention.
Secondary outcomes:
measure: Change of syndrome scales from baseline at 8 weeks;
timeFrame: Within 8 weeks of completion intervention.
measure: Change of YGTSS scores from baseline at 2 weeks;
timeFrame: within 2 weeks of intervention
measure: Change of syndrome scales from baseline at 2 weeks;
timeFrame: Within 2 weeks of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing University of TCM affiliated hospital
name: Xinmin Han, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Yi zheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Medical college Attached Brain Branch Hospital
name: Minjie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Xiaowei Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Yan Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Xuefeng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University of TCM affiliated hospital
name: Yuyan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan University of TCM affiliated hospital
name: Ying Ding, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.