Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00275912
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2006-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000078330', 'term': 'Oxcarbazepine'}], 'ancestors': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epileptic activity at electroencephalography in rest'}, {'measure': 'Flash light and hyperventilation test with electroencephalography'}, {'measure': "Frequency of epileptic episodes according to patient's diary"}, {'measure': 'Electrocardiogram analysis for rhythm and conduction'}, {'measure': 'Blood test for sodium, hepatic enzymes and blood cells'}], 'secondaryOutcomes': [{'measure': "Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures"}, {'measure': 'Rate of patients with total and partial control of epilepsy'}, {'measure': 'Rate of patients requiring additional antiepileptic drugs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy, Partial Seizures']}, 'descriptionModule': {'briefSummary': 'This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females, 6 months - 17 years of age;\n* diagnosis of epilepsy, partial seizures;\n* ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy\n\nExclusion Criteria:\n\n* progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;\n* non-epileptic seizures;\n* drug or alcohol dependence during a year prior to screening;\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00275912', 'briefTitle': 'Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-week Prospective Open-label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures', 'orgStudyIdInfo': {'id': 'CTRI476BRU02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oxcarbazepine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian State Medical University clinically based on Russian Pediatric Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Pediatrics Medical Academy', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}