Phase III Study of 5LGr to Treat Tic Disorder (5LGr)
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ClinicalTrials.gov Identifier: NCT01501695 |
Recruitment Status :
Completed
First Posted : December 29, 2011
Last Update Posted : December 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tic Disorder Tourette Syndrome Chronic Tic Disorder | Drug: 5LGr Drug: tiapride Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 603 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 5LGr, granule and placebo tablet
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. |
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.
Other Name: Wuling Granule |
Active Comparator: tiapride tabletand mimic 5LGr granule
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. |
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. Other Name: Tiapridel, Tiapridax |
Placebo Comparator: placebo, granule and tablet
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. |
Drug: placebo
mimetic granule: same with 5LGr mimetic tablet: same with tiapride
Other Name: Blank tablet |
- 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.
- Change of syndrome scales from baseline at 8 weeks; [ Time Frame: Within 8 weeks of completion intervention. ]
- Change of YGTSS scores from baseline at 2 weeks; [ Time Frame: within 2 weeks of intervention ]
- Change of syndrome scales from baseline at 2 weeks; [ Time Frame: Within 2 weeks of intervention ]

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Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501695
Principal Investigator: | Xinmin Han, M.D. | Nanjing University of TCM affiliated hospital | |
Principal Investigator: | Yi zheng | Capital Medical University | |
Principal Investigator: | Minjie Wang, M.D. | Nanjing Medical college Attached Brain Branch Hospital | |
Principal Investigator: | Xiaowei Wei, M.D. | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | |
Principal Investigator: | Yan Cheng, M.D. | Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine | |
Principal Investigator: | Xuefeng Wang, M.D. | The Affiliated Hospital of Liaoning University of TCM | |
Principal Investigator: | Yuyan Chen, M.D. | Zhejiang University of TCM affiliated hospital | |
Principal Investigator: | Ying Ding, M.D. | Henan University of TCM affiliated hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tasly Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01501695 |
First Posted: | December 29, 2011 Key Record Dates |
Last Update Posted: | December 12, 2012 |
Last Verified: | December 2012 |
tic disorder pediatric |
Tourette Syndrome Tics Tic Disorders Disease Pathologic Processes Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Tiapride Hydrochloride Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |