Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT05493293
Status:
TERMINATED
Last Update Posted:
2024-04-12
First Post:
2022-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], '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'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'For participants who enroll directly from Study NBI-921352-FOS2021, the study will include a Blinded Dose Conversion Period (1 week) before proceeding to the Open-Label Treatment Period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'whyStopped': 'The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2022-08-05', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of serious treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Through Week 111'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epilepsy', 'focal seizure', 'sodium channel', 'voltage-gated', 'alpha subunit', 'Nav1.6 inhibitor', 'antiseizure medicine', 'ASM', 'antiepileptic drug', 'AED', 'partial seizure', 'partial onset epilepsy'], 'conditions': ['Focal Onset Seizure', 'Focal Onset Epilepsy']}, 'descriptionModule': {'briefSummary': 'This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Provided informed consent.\n* Completed 11 weeks of treatment in Study NBI-921352-FOS2021.\n* Stable treatment with at least 1 but not more than 4 antiseizure medicines.\n\nKey Exclusion Criteria:\n\n* Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.'}, 'identificationModule': {'nctId': 'NCT05493293', 'briefTitle': 'Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)', 'orgStudyIdInfo': {'id': 'NBI-921352-FOS2022'}, 'secondaryIdInfos': [{'id': '2021-004265-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI-921352 Treatment', 'description': 'Treatment for up to 107 weeks.', 'interventionNames': ['Drug: NBI-921352']}], 'interventions': [{'name': 'NBI-921352', 'type': 'DRUG', 'description': 'Tablets for oral administration', 'armGroupLabels': ['NBI-921352 Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3065', 'city': 'Fitzroy', 'country': 'Australia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3084', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '16000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '18600', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '51601', 'city': 'Rychnov nad Kněžnou', 'country': 'Czechia', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.16284, 'lon': 16.27488}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 48.11109, 'lon': 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45.19205, 'lon': 9.15917}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Clinical Development Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}