Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-03-24 @ 5:39 PM
Study NCT ID:
NCT00292461
Status:
COMPLETED
Last Update Posted:
2013-05-20
First Post:
2006-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078305', 'term': 'Zonisamide'}, {'id': 'D000077213', 'term': 'Lamotrigine'}], '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': 'D014227', 'term': 'Triazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '81-3-3817-3914', 'title': 'Takao Ishii, Asia regulatory affaires', 'organization': 'Eisai Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks', 'otherNumAtRisk': 34, 'otherNumAffected': 20, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks', 'otherNumAtRisk': 30, 'otherNumAffected': 20, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Disturbance in attention', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'dizziness', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Gait disturbance', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'insomnia', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'nystagmus', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'somnolence', 'notes': 'derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'White blood cell urine positive', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Blood alkaline phosphatase increased', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Electrocardiogram abnormal', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Hepatic enzyme abnormal', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Red blood cell urine positive', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Weight decreased', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Mood altered', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'nausia', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal distention', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'anorexia', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'malaise', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'splenomegaly', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hepatic function disorders', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'contusion', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'pruritus', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'rash', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'diplopia', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Vision blurred', 'notes': 'Derived from Table for all drug-related AEs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'Lumber contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '180.0'}, {'value': '-35.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '444.4'}]}]}], 'analyses': [{'pValue': '0.240', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Percentage Change of Frequency = (T-B)/B\\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\\* 4 B= The monthly seizure frequence with one month prior to enrollment', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intent-to-treat)'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}], 'classes': [{'title': 'Greatly improved', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat improved', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Greatly worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.460', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 16 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}], 'classes': [{'title': 'Greatly improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat improved', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Somewhat worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Greatly worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 16 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 16 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'FG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonegran', 'description': 'once or twice daily orally for 16 weeks'}, {'id': 'BG001', 'title': 'Lamotrigine', 'description': 'once daily orally for 16 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', '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': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2006-02-14', 'resultsFirstSubmitDate': '2010-09-27', 'studyFirstSubmitQcDate': '2006-02-14', 'lastUpdatePostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-20', 'studyFirstPostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Percentage Change of Frequency = (T-B)/B\\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\\* 4 B= The monthly seizure frequence with one month prior to enrollment'}], 'secondaryOutcomes': [{'measure': 'Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period', 'timeFrame': 'Baseline and 16 weeks'}, {'measure': 'Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period', 'timeFrame': 'Baseline and 16 weeks'}, {'measure': 'Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.', 'timeFrame': 'Baseline and 16 weeks'}]}, 'conditionsModule': {'keywords': ['Epilepsy', 'seizures'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects must sign and date the informed consent form\n* Clinical diagnosis as refractory epilepsy\n\nExclusion criteria:\n\n* Progressive neurologic disease\n* Serious psychiatric disease\n* Hemolytic anemia\n* G6PD (glucose-6-phosphate dehydrogenase) deficiency\n* Acute intermittent porphyrias\n* Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past\n* Drug or alcohol addiction\n* Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST \\> 2x ULN)\n* Stevens-Johnson syndrome\n* Progressive exfoliative dermatitis\n* Pregnant, lactating or of childbearing potential female\n* Regularly taking oral contraceptives\n* Hypersensitivity to study drugs\n* Severe cardiac disease (New York Heart Association Functional Class III and IV)\n* History of malignancy within 5 years\n\n * Taking valproic acid within 7 days prior to screening\n * Subjects with simple partial seizures without motor component'}, 'identificationModule': {'nctId': 'NCT00292461', 'briefTitle': 'A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures', 'orgStudyIdInfo': {'id': 'E2090-AS886-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'zonisamide', 'description': 'tablet', 'interventionNames': ['Drug: Zonisamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lamotrigine', 'description': 'tablet', 'interventionNames': ['Drug: Lamotrigine']}], 'interventions': [{'name': 'Zonisamide', 'type': 'DRUG', 'description': 'Tablet once or twice daily orally for 16 weeks', 'armGroupLabels': ['zonisamide']}, {'name': 'Lamotrigine', 'type': 'DRUG', 'description': 'Tablet once daily orally for 16 weeks', 'armGroupLabels': ['lamotrigine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'state': 'Taiwan', 'country': 'China', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 29.90718, 'lon': 118.61765}}, {'city': 'Kaohsiung', 'state': 'Taiwan', 'country': 'China', 'facility': 'Chang-Gung Memorial Hospital (CGMH)'}, {'city': 'Linkou', 'state': 'Taiwan', 'country': 'China', 'facility': 'Chang-Gung Memorial Hospital (CGMH)', 'geoPoint': {'lat': 45.2762, 'lon': 130.27332}}, {'city': 'Taichun', 'state': 'Taiwan', 'country': 'China', 'facility': 'China Medical University Hospital (CMUH)'}, {'city': 'Tainan', 'state': 'Taiwan', 'country': 'China', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 32.76205, 'lon': 120.26944}}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'China', 'facility': 'Chang-Gung Memorial Hospital (CGMH)'}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'China', 'facility': 'Taipei Tzu Chi General Hospital'}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'China', 'facility': 'Taipei Veterans General Hospital'}], 'overallOfficials': [{'name': 'Ya-Hui Cheng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}