Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01140867
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2010-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
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'}], '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'}]}}, '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}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.', 'otherNumAtRisk': 121, 'otherNumAffected': 78, 'seriousNumAtRisk': 121, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 37, 'numAffected': 34}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Nervous system disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations'}], 'seriousEvents': [{'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seizure Reduction Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.35', 'spread': '436', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 weeks', 'description': 'The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.', 'unitOfMeasure': 'Percentage of Seizure Reduction Rate', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Seizure Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'The percentage of the participants who experienced no seizure during the trial.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 16 weeks', 'description': 'The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'QoL-QOLIE31 (Quality of Life in Epilepsy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'classes': [{'title': 'Baseline- Pre-QOLIE 31 total score (N=90)', 'categories': [{'measurements': [{'value': '56.67', 'spread': '15.97', 'groupId': 'OG000'}]}]}, {'title': '16 weeks - Post- QOLIE 31 total score (N=90)', 'categories': [{'measurements': [{'value': '57.70', 'spread': '15.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 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', 'populationDescription': 'Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Uncooperative patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Medication Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was recruited at 10 centers in Korea during the period of February 2008 to August 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zonisamide', 'description': 'Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.70', 'spread': '11.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2010-05-19', 'resultsFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-05', 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure Reduction Rate', 'timeFrame': 'Baseline and 16 weeks', 'description': 'The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.'}], 'secondaryOutcomes': [{'measure': 'Seizure Free Rate', 'timeFrame': '16 weeks', 'description': 'The percentage of the participants who experienced no seizure during the trial.'}, {'measure': 'Responder Rate', 'timeFrame': 'Baseline and 16 weeks', 'description': 'The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.'}, {'measure': 'QoL-QOLIE31 (Quality of Life in Epilepsy)', 'timeFrame': 'Baseline and 16 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 object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.', 'detailedDescription': "The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \\~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures \\[SPS\\], complex partial seizures \\[CPS\\], simple partial seizures evolving into generalized tonic-clonic convulsions \\[SGTC\\] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Epilepsy patient over 15 years old who agrees with Informed Consent Form\n2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.\n3. Patient who has 3 \\~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 \\~ 3 antiepileptic drug(s).\n4. Patient who takes 1 \\~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.\n5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.\n\nExclusion criteria:\n\n1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.\n2. Patient who experiences pseudoseizures and/or who has uncountable clusters.\n3. Patient who has serious systemic or drug metabolism affecting disorder .\n4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.\n5. Patient who has absolute neutrophil counts \\<1800/mm3 or platelets \\<100,000/mm3.\n6. Patient who has medical history of renal stones.\n7. Patient who is allergic to sulfonamide.\n8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.\n9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.\n10. A terminal patient and/or a scheduled surgical patient.\n11. Patient who has medication history of zonisamide.\n12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.'}, 'identificationModule': {'nctId': 'NCT01140867', 'briefTitle': 'Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy', 'orgStudyIdInfo': {'id': 'E2090-S082-409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: zonisamide']}], 'interventions': [{'name': 'zonisamide', 'type': 'DRUG', 'description': 'zonisamide 100 mg tablet', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital, Dept. of Neurology', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje Univ. Pusan Paik Hospital, Dept. of Neurology', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook Natl. Univ. Hosp., Dept. of Neurology', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam Univ. Medical Center, Dept. of Neurology', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon Medical School Gil Medical Centre, Dept.of Neurology', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Koyang', 'country': 'South Korea', 'facility': 'Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology'}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bundang CHA Hospital, Dept. of Neurology', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hosp., Dept. of Neurology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Dept. of Neurology', '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'}}}}