Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT01501695
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2011-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study of 5LGr to Treat Tic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-03-19', 'releaseDate': '2015-03-10'}, {'resetDate': '2015-12-17', 'releaseDate': '2015-11-16'}], 'estimatedResultsFirstSubmitDate': '2015-03-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013981', 'term': 'Tic Disorders'}, {'id': 'D005879', 'term': 'Tourette Syndrome'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063325', 'term': 'Tiapride Hydrochloride'}], 'ancestors': [{'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 603}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2011-12-26', 'studyFirstSubmitQcDate': '2011-12-26', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks', 'timeFrame': 'Within 8 weeks of completion intervention.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change of syndrome scales from baseline at 8 weeks;', 'timeFrame': 'Within 8 weeks of completion intervention.'}, {'measure': 'Change of YGTSS scores from baseline at 2 weeks;', 'timeFrame': 'within 2 weeks of intervention'}, {'measure': 'Change of syndrome scales from baseline at 2 weeks;', 'timeFrame': 'Within 2 weeks of intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tic disorder', 'pediatric'], 'conditions': ['Tic Disorder', 'Tourette Syndrome', 'Chronic Tic Disorder']}, 'referencesModule': {'references': [{'pmid': '26072932', 'type': 'DERIVED', 'citation': 'Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.'}], 'seeAlsoLinks': [{'url': 'http://www.tasly.com', 'label': 'Manufacturer'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>1 year history of diagnosed tic disorder;\n* age:5-18 yrs;\n* YGTSS score\\>=30 at baseline.\n\nExclusion Criteria:\n\n* Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.\n* Any indefinite tic disorder or tic disorders caused by medication.\n* Participation to other studies.\n* Patients with loose stool."}, 'identificationModule': {'nctId': 'NCT01501695', 'acronym': '5LGr', 'briefTitle': 'Phase III Study of 5LGr to Treat Tic Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasly Pharmaceuticals, Inc.'}, 'officialTitle': 'A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder', 'orgStudyIdInfo': {'id': 'NCT00797953'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5LGr, granule and placebo tablet', '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.\n\nMimic 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.\n\nDuration: 8 weeks.', 'interventionNames': ['Drug: 5LGr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tiapride tabletand mimic 5LGr granule', 'description': 'Tiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo.\n\nDosage: 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.\n\nMimic 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.\n\nDuration: 8 weeks.', 'interventionNames': ['Drug: tiapride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo, granule and tablet', 'description': "This arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients.\n\nDosage 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.\n\nMimic 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.\n\nDuration: 8 weeks.", 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': '5LGr', 'type': 'DRUG', 'otherNames': ['Wuling Granule'], 'description': '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.', 'armGroupLabels': ['5LGr, granule and placebo tablet']}, {'name': 'tiapride', 'type': 'DRUG', 'otherNames': ['Tiapridel, Tiapridax'], 'description': '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.\n\nTotal duration:8 weeks.', 'armGroupLabels': ['tiapride tabletand mimic 5LGr granule']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Blank tablet'], 'description': 'mimetic granule: same with 5LGr mimetic tablet: same with tiapride', 'armGroupLabels': ['placebo, granule and tablet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xinmin Han, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing University of TCM affiliated hospital'}, {'name': 'Yi zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Medical University'}, {'name': 'Minjie Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Medical college Attached Brain Branch Hospital'}, {'name': 'Xiaowei Wei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine'}, {'name': 'Yan Cheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine'}, {'name': 'Xuefeng Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine'}, {'name': 'Yuyan Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University of TCM affiliated hospital'}, {'name': 'Ying Ding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan University of TCM affiliated hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasly Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-03-10', 'type': 'RELEASE'}, {'date': '2015-03-19', 'type': 'RESET'}, {'date': '2015-11-16', 'type': 'RELEASE'}, {'date': '2015-12-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tasly Pharmaceuticals, Inc.'}}}}