Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-07 @ 12:40 AM
Study NCT ID:
NCT00659958
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2008-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of seizures.', 'timeFrame': 'Evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks had passed.'}], 'secondaryOutcomes': [{'measure': 'Quality of life, tolerability.', 'timeFrame': 'Quality of Life evaluations will be done at the beginning of the study (enrollment visit) and then one more time when 24 weeks have passed. Tolerability will be assessed at the beginning of the study (enrollment visit) and at 12, 18, and 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['zonisamide', 'partial onset seizures', 'effectiveness', 'tolerability'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs.', 'detailedDescription': 'Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed consent, will be included in the study.\n\nTo these patients, physicians will prescribe zonisamide in the following manner: Titration period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable.\n\nDrugs will be prescribed by the physician and purchased by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included.\n\nExclusion Criteria:\n\nThose who do not fulfill the Inclusion requirements.'}, 'identificationModule': {'nctId': 'NCT00659958', 'briefTitle': 'ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Post-authorization, Observational and Prospective Follow up Study to Evaluate Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs', 'orgStudyIdInfo': {'id': 'E2090-E044-407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Zonisamide']}], 'interventions': [{'name': 'Zonisamide', 'type': 'DRUG', 'otherNames': ['Zonegran'], 'description': '300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'Galicia', 'country': 'Spain', 'facility': "Complejo Hospitalario Universitario 'Juan Canalejo'", 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15405', 'city': 'Ferrol', 'state': 'Galicia', 'country': 'Spain', 'facility': 'C.H. A. Marcide Profesor Novoa Santos', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '27004', 'city': 'Lugo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Centro Sanitario Complexo Hospitalario "XERAL-CALDE"', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '27400', 'city': 'Lugo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Comarcal de Monforte', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '27880', 'city': 'Lugo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Centro Sanitario Hospital Da Costa de Burela', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '32005', 'city': 'Ourense', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '36071', 'city': 'Pontevedra', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '36204', 'city': 'Vigo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Meixoeiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '36211', 'city': 'Vigo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Povisa', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '63204', 'city': 'Vigo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo (CHUVI), Hospital Xeral-Cies', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'Jesus De Rosendo', 'role': 'STUDY_CHAIR', 'affiliation': 'EISAI Farmaceutica S.A. Head of Medical Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eisai Farmacêutica S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}