Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT05301894
Status:
TERMINATED
Last Update Posted:
2025-02-28
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to 238 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Epileptic Encephalopathy', 'Neurocrine', 'NBI-827104', 'Steamboat 2'], 'conditions': ['Epileptic Encephalopathy', 'Continuous Spike and Wave During Sleep']}, 'descriptionModule': {'briefSummary': 'The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).', 'detailedDescription': 'This study will enroll participants who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010 (NCT04625101). Participants who did not participate in Study NBI-827104-CSWS2010 may also be eligible for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nFor participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:\n\n* Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.\n\nFor Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:\n\n* Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP).\n\nKey Exclusion Criteria:\n\nFor participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:\n\n* Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.\n\nFor Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:\n\n* Body weight \\<15 kg at Day 1.\n* Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.\n* Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening.\n* Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.\n* Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study.\n* Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.'}, 'identificationModule': {'nctId': 'NCT05301894', 'acronym': 'Steamboat 2', 'briefTitle': 'Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurocrine Biosciences'}, 'officialTitle': 'Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep', 'orgStudyIdInfo': {'id': 'NBI-827104-CSWS2025'}, 'secondaryIdInfos': [{'id': '2021-006788-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI-827104', 'description': 'NBI-827104 administered orally', 'interventionNames': ['Drug: NBI-827104']}], 'interventions': [{'name': 'NBI-827104', 'type': 'DRUG', 'description': 'T-type calcium channel blocker.', 'armGroupLabels': ['NBI-827104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '4293', 'city': 'Dianalund', 'country': 'Denmark', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 55.53133, 'lon': 11.4925}}, {'zip': '08950', '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': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Neurocrine Clinical Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Development Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocrine Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurocrine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}