Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 7:03 AM
Study NCT ID:
NCT00050934
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2002-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Epilepsy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2002-12-30', 'studyFirstSubmitQcDate': '2002-12-31', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)'}], 'secondaryOutcomes': [{'measure': '% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).'}]}, 'conditionsModule': {'keywords': ['partial seizures'], 'conditions': ['Epilepsy', 'Epilepsies, Partial']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA: To enter this study, patients must:\n\n* Have a diagnosis of partial seizures\n* Be willing to be hospitalized\n* Weigh a minimum of 6.6 pounds\n* Be taking a stable dose of one to two concomitant anti-epileptic medications\n* Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease\n* Have normal laboratory results\n\nEXCLUSION CRITERIA: To enter this study, a patient must not have or be:\n\n* Seizures caused by metabolic disturbance, toxic exposure, or active infection\n* A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)\n* A history of status epilepticus within 30 days\n* Seizures not related to epilepsy\n* Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam)\n* Taking felbamate within 6 months\n* Serum sodium levels \\<135 mEq/L\n* Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy\n* A history of chronic infection (e.g., hepatitis or HIV)\n* Significant electrocardiogram (ECG) abnormalities\n* A nursing mother taking anti-convulsant drugs\n* Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds\n* Used experimental medication within 30 days of entering this study'}, 'identificationModule': {'nctId': 'NCT00050934', 'briefTitle': 'Pediatric Epilepsy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.', 'orgStudyIdInfo': {'id': 'CTRI476E 2340'}}, 'armsInterventionsModule': {'interventions': [{'name': 'oxcarbazepine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '19806', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63017', 'city': 'Chesterfields', 'state': 'Missouri', 'country': 'United States'}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '01401-901', 'city': 'Sao Paulo - SP', 'country': 'Brazil', 'facility': 'Brigadeiro Hospital'}, {'zip': '77694', 'city': 'Kehl-Kork', 'country': 'Germany'}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Novartis', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}