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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01501695

Acronym

5LGr

Enrollment

603

Registered

2011-12-29

Start date

2008-01-31

Completion date

2011-10-31

Last updated

2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic Disorder, Tourette Syndrome, Chronic Tic Disorder

Keywords

tic disorder, pediatric

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.

Interventions

DRUG5LGr

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.

DRUGtiapride

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.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks	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

Measure	Time frame
Change of syndrome scales from baseline at 8 weeks;	Within 8 weeks of completion intervention.
Change of YGTSS scores from baseline at 2 weeks;	within 2 weeks of intervention
Change of syndrome scales from baseline at 2 weeks;	Within 2 weeks of intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026