Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-12 @ 2:58 AM
Study NCT ID:
NCT01405950
Status:
TERMINATED
Last Update Posted:
2013-06-17
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C023754', 'term': 'tizanidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hhenney@acorda.com', 'phone': '914-347-4300', 'title': 'Herbert Henney, PharmD', 'phoneExt': '5138', 'organization': 'Acorda Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days.', 'description': 'Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start-date/time of administration of study drug and no more than 1 day after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Level 1', 'description': 'Zanaflex Capsules : 0.025 mg/kg', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose Level 2', 'description': 'Zanaflex Capsules : 0.05 mg/kg', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1', 'description': 'Zanaflex Capsules : 0.025 mg/kg'}, {'id': 'OG001', 'title': 'Dose Level 2', 'description': 'Zanaflex Capsules : 0.05 mg/kg'}, {'id': 'OG002', 'title': 'Dose Level 3', 'description': 'Zanaflex Capsules: 0.075 mg/kg'}, {'id': 'OG003', 'title': 'Dose Level 4', 'description': 'Zanaflex Capsules: 0.1 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.60', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '6.11', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours', 'description': 'Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day\n\n0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine\n\nPK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).', 'unitOfMeasure': 'hour*nanogram/mililiter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics Population'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1', 'description': 'Zanaflex Capsules : 0.025 mg/kg'}, {'id': 'OG001', 'title': 'Dose Level 2', 'description': 'Zanaflex Capsules : 0.05 mg/kg'}, {'id': 'OG002', 'title': 'Dose Level 3', 'description': 'Zanaflex Capsules: 0.075 mg/kg'}, {'id': 'OG003', 'title': 'Dose Level 4', 'description': 'Zanaflex Capsules: 0.1 mg/kg'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours', 'description': 'Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day\n\n0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine\n\nPK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).', 'unitOfMeasure': 'nanogram/mililiter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1', 'description': 'Zanaflex Capsules : 0.025 mg/kg'}, {'id': 'FG001', 'title': 'Dose Level 2', 'description': 'Zanaflex Capsules : 0.05 mg/kg'}, {'id': 'FG002', 'title': 'Dose Level 3', 'description': 'Zanaflex Capsules : 0.075 mg/kg'}, {'id': 'FG003', 'title': 'Dose Level 4', 'description': 'Zanaflex Capsules : 0.1 mg/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1', 'description': 'Zanaflex Capsules : 0.025 mg/kg'}, {'id': 'BG001', 'title': 'Dose Level 2', 'description': 'Zanaflex Capsules : 0.05 mg/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '2-3 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '4-5 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '6-12 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '13-16 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': "Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2011-07-25', 'resultsFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-27', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.', 'timeFrame': 'Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours', 'description': 'Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day\n\n0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine\n\nPK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.', 'timeFrame': 'Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours', 'description': 'Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day\n\n0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine\n\nPK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spasticity Due to Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.', 'detailedDescription': "Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have clinically diagnosed spasticity resulting from cerebral palsy\n* Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years\n* Have mild to moderate spasticity at screening\n* Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study\n\nExclusion Criteria:\n\n* Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components\n* Have dietary restrictions or food allergies that conflict with a standardized meal\n* Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention\n* Have an ongoing seizure disorder that requires medical therapy'}, 'identificationModule': {'nctId': 'NCT01405950', 'briefTitle': 'Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorda Therapeutics'}, 'officialTitle': 'Single-Dose, Phase 1b Study to Assess Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects With Mild to Moderate Spasticity Due to Cerebral Palsy', 'orgStudyIdInfo': {'id': 'AT10-ZC-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'interventionNames': ['Drug: Zanaflex Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'interventionNames': ['Drug: Zanaflex Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'interventionNames': ['Drug: Zanaflex Capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'interventionNames': ['Drug: Zanaflex Capsules']}], 'interventions': [{'name': 'Zanaflex Capsules', 'type': 'DRUG', 'otherNames': ['tizanidine HCI (hydrochloride)'], 'description': '0.025 mg/kg', 'armGroupLabels': ['Dose Level 1']}, {'name': 'Zanaflex Capsules', 'type': 'DRUG', 'otherNames': ['tizanidine HCI (hydrochloride)'], 'description': '0.05 mg/kg', 'armGroupLabels': ['Dose Level 2']}, {'name': 'Zanaflex Capsules', 'type': 'DRUG', 'otherNames': ['tizanidine HCI (hydrochloride)'], 'description': '0.075 mg/kg', 'armGroupLabels': ['Dose Level 3']}, {'name': 'Zanaflex Capsules', 'type': 'DRUG', 'otherNames': ['tizanidine HCI (hydrochloride)'], 'description': '0.1 mg/kg', 'armGroupLabels': ['Dose Level 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Herbert Henney, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acorda Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acorda Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}