Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-18 @ 8:43 AM
Study NCT ID:
NCT02790632
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D017542', 'term': 'Aneurysm, Ruptured'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000783', 'term': 'Aneurysm'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716088', 'term': 'EG-1962'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 374}}, 'statusModule': {'whyStopped': 'DMC review concluded study has a low probability of meeting its primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2016-05-31', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '90 Days', 'description': 'Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine'}, {'measure': 'Delayed Cerebral Infarction', 'timeFrame': '30 Days', 'description': 'Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]', 'timeFrame': '90 Days', 'description': 'Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]', 'timeFrame': '90 Days', 'description': 'Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aneurysm, Ruptured', 'Nimodipine', 'Subarachnoid Hemorrhage'], 'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'referencesModule': {'references': [{'pmid': '32138631', 'type': 'DERIVED', 'citation': 'Carlson AP, Hanggi D, Wong GK, Etminan N, Mayer SA, Aldrich F, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Bleck T, Grubb R Jr, Miller M, Suarez JI, Proskin HM, Macdonald RL; NEWTON Investigators. Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1142-1149. doi: 10.1161/STROKEAHA.119.027396. Epub 2020 Mar 6.'}, {'pmid': '30014184', 'type': 'DERIVED', 'citation': 'Hanggi D, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Macdonald RL; NEWTON Investigators. Clinical Trial Protocol: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)]. Neurocrit Care. 2019 Feb;30(1):88-97. doi: 10.1007/s12028-018-0575-z.'}]}, 'descriptionModule': {'briefSummary': 'This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling\n2. External ventricular drain in place\n3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale\n4. WFNS grade 2, 3, or 4\n\nExclusion Criteria:\n\n1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm\n2. Angiographic vasospasm prior to randomization\n3. Evidence of a cerebral infarction with neurological deficit'}, 'identificationModule': {'nctId': 'NCT02790632', 'acronym': 'NEWTON2', 'briefTitle': 'Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edge Therapeutics Inc'}, 'officialTitle': 'Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'EG-01-1962-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EG-1962 Group', 'description': '* 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg\n* Up to 21 days of placebo capsules/tablets', 'interventionNames': ['Drug: EG-1962 (nimodipine microparticles)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral Nimodipine Group', 'description': '* 1 dose of intraventricular normal saline\n* Up to 21 days of oral nimodipine capsules/tablets', 'interventionNames': ['Drug: Enteral Nimodipine']}], 'interventions': [{'name': 'EG-1962 (nimodipine microparticles)', 'type': 'DRUG', 'description': 'Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days', 'armGroupLabels': ['EG-1962 Group']}, {'name': 'Enteral Nimodipine', 'type': 'DRUG', 'description': 'Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD', 'armGroupLabels': ['Enteral Nimodipine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Dignity 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