Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01051193
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2010-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2010-01-15', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability (adverse events, laboratory tests, vital signs, electrocardiogram (ECG))', 'timeFrame': '52 weeks and until approval/launch'}], 'secondaryOutcomes': [{'measure': 'Percent change in the partial seizure frequency per 28 days during the double-blind period from the screening period', 'timeFrame': '52 weeks and until approval/launch'}, {'measure': 'Seizure Frequency of specific duration', 'timeFrame': '52 weeks and until approval/launch'}, {'measure': 'Responder rate: defined as the proportion of patients with an at least 50% reduction in the partial epileptic seizure frequency', 'timeFrame': '52 weeks and until approval/launch'}, {'measure': 'Percent changes in the seizure frequency by subtype', 'timeFrame': '52 weeks and until approval/launch'}, {'measure': 'Clinical Global Impression of Change', 'timeFrame': '52 weeks and until approval/launch'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Seizures', 'oxcarbazepine', 'child'], 'conditions': ['Partial Onset Seizures']}, 'descriptionModule': {'briefSummary': 'This study is designed to provide long term safety data of TRI476 in children with inadequately-controlled partial seizures. This study is conducted in patients who complete the core study CTRI476B1301. Blinding is maintained during the transition and dose adjustment phase of the extension study. All patients are treated with TRI476 from the dose adjustment phase onwards. The purpose of study is to confirm that TRI476 as adjunctive therapy is safe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who completed the double-blind treatment phase of the core study (B1301).\n* A parent/legal guardian must be present and give written consent for all patients enrolled in this trial. Patients consent must be obtained using assent document according to patients age.\n* Females of childbearing potential must have a negative pregnancy test at Week 8 in the core study B1301.\n\nExclusion Criteria:\n\n* Patients with medical ineligibility to enter the extension, as assessed by the investigator at each site.\n* Patients who participated in the core study, but did not complete it (prematurely discontinued)\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01051193', 'briefTitle': 'Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': 'A Multicentre, Open-label, Extension Study in Children With Inadequately Controlled Partial Onset Seizures to Investigate Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) as Adjunctive Therapy', 'orgStudyIdInfo': {'id': 'CTRI476B1301E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRI476', 'description': 'TRI476', 'interventionNames': ['Drug: Oxcarbazepine']}], 'interventions': [{'name': 'Oxcarbazepine', 'type': 'DRUG', 'armGroupLabels': ['TRI476']}]}, 'contactsLocationsModule': {'locations': [{'zip': '460-0004', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '474-8710', 'city': 'Ōbu', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.01756, 'lon': 136.94947}}, {'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '041-1111', 'city': 'Kameda-gun', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'NPC Investigative Site'}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '670-8540', 'city': 'Himeji', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'zip': '658-0032', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '244-0842', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '861-1196', 'city': 'Kōshi', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 32.89271, 'lon': 130.77567}}, {'zip': '945-8585', 'city': 'Kashiwazaki', 'state': 'Niigata', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 37.36667, 'lon': 138.55}}, {'zip': '879-5593', 'city': 'Yufu', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}, {'zip': '710-8522', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '572-0085', 'city': 'Neyagawa', 'state': 'Osaka', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.76615, 'lon': 135.62759}}, {'zip': '330-8777', 'city': 'Saitama', 'state': 'Saitama', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '524-0022', 'city': 'Moriyama-shi', 'state': 'Shiga', 'country': 'Japan', 'facility': 'NPC Investigative Site'}, {'zip': '420-8688', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '329-0498', 'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'NPC Investigative Site'}, {'zip': '502-8558', 'city': 'Gifu', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '950-2085', 'city': 'Niigata', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '355-0008', 'city': 'Saitama', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '990-0876', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'NPC Investigative Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NPC is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}