Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01142193
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bob.Anders@upsher-smith.com', 'phone': '763-315-2000', 'title': 'Bob Anders, Sr. Director of Clinical Operations', 'organization': 'Upsher-Smith Laboratories, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events with onset after the start of study medication and up to 30 days after the last dose of study drug are reported.', 'description': 'If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once for that SOC.', 'eventGroups': [{'id': 'EG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg', 'otherNumAtRisk': 124, 'otherNumAffected': 35, 'seriousNumAtRisk': 124, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 125, 'otherNumAffected': 14, 'seriousNumAtRisk': 125, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epileptic Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '-227.3', 'upperLimit': '100.0'}, {'value': '21.65', 'groupId': 'OG001', 'lowerLimit': '-531.2', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '17.85', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.5', 'ciLowerLimit': '8.53', 'ciUpperLimit': '28.1', 'statisticalMethod': 'Hodges-Lehmann', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '11 weeks', 'unitOfMeasure': 'Percent Reduction', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'paramValue': '14.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'paramValue': '16.3', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis was stratified by Geographic Region.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks (weeks 1-3)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33.93', 'groupId': 'OG000', 'lowerLimit': '-200.00', 'upperLimit': '100.0'}, {'value': '8.57', 'groupId': 'OG001', 'lowerLimit': '-158.3', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '25.36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 weeks (weeks 1-3)', 'unitOfMeasure': 'Percent Reduction', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39.50', 'groupId': 'OG000', 'lowerLimit': '-227.3', 'upperLimit': '100.0'}, {'value': '21.65', 'groupId': 'OG001', 'lowerLimit': '-531.2', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '17.85', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '11 weeks', 'unitOfMeasure': 'Percent Reduction', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': '≥25% reduction in seizure rate', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}]}]}, {'title': '≥75% reduction in seizure rate', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': '100% reduction in seizure rate', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks (weeks 1-3)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': '≥25% reduction in seizure rate', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '46.4', 'groupId': 'OG001'}]}]}, {'title': '≥75% reduction in seizure rate', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': '100% reduction in seizure rate', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': '≥25% reduction in seizure rate', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}]}]}, {'title': '≥75% reduction in seizure rate', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}, {'title': '100% reduction in seizure rate', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks (weeks 4-11)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '45.70', 'groupId': 'OG000', 'lowerLimit': '-237.5', 'upperLimit': '100.0'}, {'value': '22.09', 'groupId': 'OG001', 'lowerLimit': '-747.4', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'paramValue': '23.61', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks (weeks 4-11)', 'unitOfMeasure': 'Percent Reduction', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'paramValue': '13.4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis was stratified by Geographic Region.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks (weeks 4-11)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Discontinuation Criterion Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted in 16 countries (Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, and United States). At least 1 subject was enrolled at 66 study centers, of which 60 study centers randomly assigned at least 1 subject to study drug.', 'preAssignmentDetails': 'Subject had to have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days during the 8-week baseline to be randomized into the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'USL255', 'description': 'Titration of 50 mg in weekly increments over 3 weeks to 200 mg'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '10.97', 'groupId': 'BG000'}, {'value': '37.6', 'spread': '11.11', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '11.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2014-01-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2010-06-09', 'dispFirstSubmitQcDate': '2014-01-02', 'resultsFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2010-06-10', 'dispFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'timeFrame': '11 weeks'}, {'measure': 'Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.', 'timeFrame': '3 weeks (weeks 1-3)'}, {'measure': 'Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.', 'timeFrame': '3 weeks (weeks 1-3)'}, {'measure': 'Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.', 'timeFrame': '11 weeks'}, {'measure': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.', 'timeFrame': '3 weeks (weeks 1-3)'}, {'measure': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.', 'timeFrame': '11 weeks'}, {'measure': 'Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'timeFrame': '8 weeks (weeks 4-11)'}, {'measure': 'Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'timeFrame': '8 weeks (weeks 4-11)'}, {'measure': 'Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.', 'timeFrame': '8 weeks (weeks 4-11)'}]}, 'conditionsModule': {'keywords': ['Epilepsy', 'partial onset seizure', 'adjunctive therapy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '25461205', 'type': 'DERIVED', 'citation': 'Hogan RE, Blatt I, Lawson B, Nagaraddi V, Fakhoury TA, Anders B, Clark AM, Laine D, Halvorsen MB, Chung SS. Efficacy of once-daily extended-release topiramate (USL255): a subgroup analysis based on the level of treatment resistance. Epilepsy Behav. 2014 Dec;41:136-9. doi: 10.1016/j.yebeh.2014.09.061. Epub 2014 Oct 21.'}, {'pmid': '24902983', 'type': 'DERIVED', 'citation': 'Chung SS, Fakhoury TA, Hogan RE, Nagaraddi VN, Blatt I, Lawson B, Arnold S, Anders B, Clark AM, Laine D, Meadows RS, Halvorsen MB; PREVAIL Study Group. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Epilepsia. 2014 Jul;55(7):1077-87. doi: 10.1111/epi.12660. Epub 2014 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.\n* Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).\n* Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.\n\nExclusion Criteria:\n\n* Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.\n* Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.\n* Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.\n* Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.\n* Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.\n* Have taken topiramate within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT01142193', 'briefTitle': 'Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Upsher-Smith Laboratories'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive 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