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Phase III Study of 5LGr to Treat Tic Disorder

NCT01501695 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2012-12-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tasly Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Xinmin Han, M.D. · Nanjing University of TCM affiliated hospital

  • Yi zheng · Capital Medical University

  • Minjie Wang, M.D. · Nanjing Medical college Attached Brain Branch Hospital

  • Xiaowei Wei, M.D. · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  • Yan Cheng, M.D. · Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  • Xuefeng Wang, M.D. · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  • Yuyan Chen, M.D. · Zhejiang University of TCM affiliated hospital

  • Ying Ding, M.D. · Henan University of TCM affiliated hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-11-30
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501695 on ClinicalTrials.gov