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Completed

NCT Number: NCT01501695

Phase III Study of 5LGr to Treat Tic Disorder

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

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Key information

Conditions

Tic Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Tic Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders Tourette Syndrome

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5LGr

Drug

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.

Other names: Wuling Granule

tiapride

Drug

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.

Other names: Tiapridel, Tiapridax

Placebo

Drug

mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Other names: Blank tablet

Primary outcomes

  1. Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks

    Time frame: Within 8 weeks of completion intervention.

    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.

Secondary outcomes

  1. Change of syndrome scales from baseline at 8 weeks;

    Time frame: Within 8 weeks of completion intervention.

  2. Change of YGTSS scores from baseline at 2 weeks;

    Time frame: within 2 weeks of intervention

  3. Change of syndrome scales from baseline at 2 weeks;

    Time frame: Within 2 weeks of intervention

Sponsors and collaborators

Lead sponsor

Tasly Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: 5LGr

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 29, 2011
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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