Phase III Study of 5LGr to Treat Tic Disorder

Tasly Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Tic Disorder; Tourette Syndrome; Tic Disorder

Treatments: Drug: placebo; Drug: 5LGr; Drug: tiapride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01501695

NCT00797953

Details and patient eligibility

About

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

Full 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.

Enrollment: 603 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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603 participants in 3 patient groups, including a placebo group

5LGr, granule and placebo tablet

Experimental group

Description:

Drug:5LGr; Dosage form:Granule;Strength:5 gram/sack;Mimic Tablet:0 mg/tablet. Dosage: 5LGr Granule: 1 sack, t.i.d. for patients less than 12 yrs,whereas 1.5 sacks, t.i.d. for patients 13-18 yrs. Mimic tablet:For patients 5-12 yrs: 0.5 tablet, b.i.d for first 2 weeks, then 1 tablet, bid for next 6 weeks; for patients 13-18 yrs: tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks.

Treatment:

Drug: 5LGr

tiapride tabletand mimic 5LGr granule

Active Comparator group

Description:

Tiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo. Dosage: Tiaptride tablet: 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. Mimic 5LGr Granule:Strength:0 gram/sack.Dosage:1 sack for patients less than 12 yrs,while 1.5 sacks for patients 13-18 yrs.Frequency: T.i.d. Duration: 8 weeks.

Treatment:

Drug: tiapride

placebo, granule and tablet

Placebo Comparator group

Description:

This arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients. Dosage form: Mimic Granule:Strength:0 gram/sack Dosage:1 sack, t.i.d for patients less than 12 yrs,while 1.5 sacks, t.i.d for patients 13-18 yrs. Mimic tablet:Strength:0 mg/tablet.For patients 5-12 yrs: 0.5 tablets b.i.d for first 2 weeks, then 1 tablet,b.i.d for next 6 weeks; for patients 13-18 yrs:1 tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks.

Treatment:

Drug: placebo