Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01127256
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2010-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
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': 'D000078305', 'term': 'Zonisamide'}, {'id': 'D002220', 'term': 'Carbamazepine'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jihee_mun@eisaikorea.com', 'phone': '+82-2-3451-5531', 'title': 'Jihee Mun, Pharmacist, Medical Department manager', 'organization': 'Eisai Korea Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.', 'otherNumAtRisk': 96, 'otherNumAffected': 74, 'seriousNumAtRisk': 96, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.', 'otherNumAtRisk': 104, 'otherNumAffected': 70, 'seriousNumAtRisk': 104, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Nervous system disorders'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Weight Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Mental Torpor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Gastrointestinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Sleep Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Worsening Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Depressive Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Right Shoulder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Visual Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Cervical Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Memory And Judgement Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Uterine Fibroid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Sgpt Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Sgot Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Mental Torpor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Participants With Seizure Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}, {'value': '83.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who had no seizure during the trial.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With Retention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who completed the trial.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life in Epilepsy (QoL-QOLIE31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.'}], 'classes': [{'title': 'Pre-QOLIE 31', 'categories': [{'measurements': [{'value': '60.72', 'spread': '14.69', 'groupId': 'OG000'}, {'value': '61.96', 'spread': '16.67', 'groupId': 'OG001'}]}]}, {'title': 'Post-QOLIE 31', 'categories': [{'measurements': [{'value': '67.27', 'spread': '16.34', 'groupId': 'OG000'}, {'value': '69.51', 'spread': '17.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.', 'unitOfMeasure': 'Units On a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.'}, {'id': 'FG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.'}, {'id': 'BG001', 'title': 'Carbamazepine', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '98', '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': '96', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '200', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2010-05-19', 'resultsFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-06-20', 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Participants With Seizure Free Rate', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who had no seizure during the trial.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Participants With Retention Rate', 'timeFrame': '24 weeks', 'description': 'The percentage of participants who completed the trial.'}, {'measure': 'Quality of Life in Epilepsy (QoL-QOLIE31)', 'timeFrame': '24 weeks', 'description': 'Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.'}]}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.', 'detailedDescription': 'To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\\~27 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Epilepsy patients over 15 years old.\n2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.\n3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.\n4. Female who can be in the month of pregnancy should agree to prevent conception.\n5. Patients who agree with Informed Consent Form.\n\nExclusion criteria:\n\n1. Patients who have Myoclonic seizures and/or Absence seizures.\n2. Patients who have progressive central nervous system (CNS) disorder.\n3. Patients who have serious systemic disorder.\n4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.\n5. Patients who have renal stones.\n6. Medical history of medicinal poisoning and/or alcoholism.\n7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.'}, 'identificationModule': {'nctId': 'NCT01127256', 'briefTitle': 'Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation', 'orgStudyIdInfo': {'id': 'E2090-S082-405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: zonisamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: carbamazepine']}], 'interventions': [{'name': 'zonisamide', 'type': 'DRUG', 'description': 'Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.', 'armGroupLabels': ['1']}, {'name': 'carbamazepine', 'type': 'DRUG', 'description': 'Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bundang', 'country': 'South Korea', 'facility': 'Seoul National Univ. Bundang Hosp.'}, {'city': 'Ilsan', 'country': 'South Korea', 'facility': 'Dongguk Univ. Ilsan Hosp.', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha Univ. Hosp.', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jungnam', 'country': 'South Korea', 'facility': 'Chungnam National Univ. Hosp.', 'geoPoint': {'lat': 36.27333, 'lon': 128.02522}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hosp.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans Univ. Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym Univ. Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang Univ. Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk Univ. Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National Univ. Hosp.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jihee Mun', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Department, Eisai Korea Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Korea Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}