Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-27 @ 7:07 PM
Study NCT ID:
NCT01397968
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2011-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654784', 'term': 'Cenobamate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mkamin@sklsi.com', 'phone': '201-421-3830', 'title': 'Chief Medical Officer', 'organization': 'SK Life Science'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 week double-blind treatment period plus taper period (2-3 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'YKP3089', 'description': 'YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 86, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: capsule, dose to be titrated to a target dose of 200mg/day', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 69, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Drug hypersensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arteriogram coronary normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'YKP3089', 'description': 'YKP3089: Capsule, dose to be titrated Tablet, dose to be titrated'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo capsule Placebo tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '-417.3', 'upperLimit': '100.0'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '-588.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank sum', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'assessed per 28 days during 12 week period; change from baseline and 12 weeks reported', 'description': 'Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline', 'unitOfMeasure': 'percent seizure reduction', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '50% Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'YKP3089', 'description': 'YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: capsule, dose to be titrated to a target dose of 200mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'YKP3089', 'description': 'YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: capsule, dose to be titrated to a target dose of 200mg/day'}], 'periods': [{'title': 'Double-blind Period of Study YKP3089C013', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': 'Open-label Extension Study YKP3089C013', 'milestones': [{'type': 'STARTED', 'comment': 'Not all subjects moved from double-blind to open-label extension.', 'achievements': [{'comment': 'Not all subjects from double-blind rolled over to open-label.', 'groupId': 'FG000', 'numSubjects': '76'}, {'comment': 'Not all subjects from double-blind rolled over to open-label.', 'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}]}], 'recruitmentDetails': 'Enrollment occurred in 4 countries (United States, Poland, Korea, India) between 06 July 2011 and 15 June 2013 when the last subject completed the double-blind period.', 'preAssignmentDetails': 'There were 285 patients screened; 63 were excluded before assignment to study group for reasons as follows:\n\ninclusion/exclusion criteria, withdrew by patient, other, lost to follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'YKP3089', 'description': 'YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: capsule, dose to be titrated to a target dose of 200mg/day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '61'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '59'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '28-day partial-onset seizure frequency', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '187'}, {'value': '5.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '237'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '237'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'dispFirstSubmitDate': '2014-11-17', 'completionDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-08', 'studyFirstSubmitDate': '2011-07-18', 'dispFirstSubmitQcDate': '2014-11-17', 'resultsFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2011-07-19', 'dispFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-08', 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days', 'timeFrame': 'assessed per 28 days during 12 week period; change from baseline and 12 weeks reported', 'description': 'Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline'}], 'secondaryOutcomes': [{'measure': '50% Responder Rate', 'timeFrame': '12 weeks', 'description': 'Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['partial onset seizures', 'treatment resistant', 'partial epilepsy'], 'conditions': ['Partial Epilepsy']}, 'referencesModule': {'references': [{'pmid': '34254673', 'type': 'DERIVED', 'citation': 'French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.'}, {'pmid': '32409485', 'type': 'DERIVED', 'citation': 'Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.'}, {'pmid': '23219031', 'type': 'DERIVED', 'citation': 'Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.\n\nAlso to evaluate the safety and tolerability of YKP3089.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of treatment resistant partial epilepsy;\n* History of epilepsy for at least 2 years;\n* Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.\n* Currently treated on a stable dose of :\n\n * 1 - 3 AED's for at least 12 weeks prior to randomization.\n * VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.\n * Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.\n\nExclusion Criteria:\n\n1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.\n2. Subject has had status epilepticus within past 1 year.\n3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.\n4. Subjects taking felbamate with less than 18 months continuous exposure.\n5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.\n6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.\n7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.\n8. Subject meets criteria for current major depressive episode (within 6 months).\n9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1."}, 'identificationModule': {'nctId': 'NCT01397968', 'briefTitle': 'Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Life Science, Inc.'}, 'officialTitle': 'A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'YKP3089C013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YKP3089', 'interventionNames': ['Drug: YKP3089']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'YKP3089', 'type': 'DRUG', 'otherNames': ['cenobamate'], 'description': 'Capsule, dose to be titrated Tablet, dose to be titrated', 'armGroupLabels': ['YKP3089']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule Placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'St. Joseph Hospital & Medical Center/Barrow Neurology Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Trials, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Research Center, Inc.', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Epilepsy Research, LLC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "John's Hopkins University School of Medicine", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Epilepsy and Sleep Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Suite 209 South', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'The University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Comprehensive Epilepsy Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurological Clinic of Texas, P.A.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '500 018', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': "St. Theresa's General Hospital"}, {'zip': '560 054', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'M.S. Ramaiah Medical College and Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560043', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Bangalore Clinisearch', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '575 002', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mallikatta Neuro Centre', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Deenanath Mangeshkar Hospital & Research Centre', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110 017', 'city': 'Sāket', 'state': 'New Delhi', 'country': 'India', 'facility': 'Max Super Specialty Hospital', 'geoPoint': {'lat': 22.63243, 'lon': 77.75516}}, {'zip': '700 071', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Nightingale Hospital', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '44-100', 'city': 'Gliwice', 'country': 'Poland', 'facility': 'NZOZ Vito-Med Sp. Zo.o', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'zip': '40-594', 'city': 'Katowice', 'country': 'Poland', 'facility': 'NZOZ Diagnomed', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-635', 'city': 'Katowice', 'country': 'Poland', 'facility': 'SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '30-510', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Malopolskie Centrum Medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-209', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Leczenia Padaczki i Migreny', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '90-242', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centrum Terapii Wspolczesnej', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '60-539', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Solumed s.c.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Medical Center', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '301-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '431-070', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Marc Kamin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SK Life Science, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Life Science, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}