Brief Summary
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
Brief Title
Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Categories
Completion Date
Completion Date Type
Actual
Conditions
Subarachnoid Hemorrhage, Aneurysmal
Eligibility Criteria
Inclusion Criteria:
1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4
Exclusion Criteria:
1. 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
2. Angiographic vasospasm prior to randomization
3. Evidence of a cerebral infarction with neurological deficit
1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4
Exclusion Criteria:
1. 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
2. Angiographic vasospasm prior to randomization
3. Evidence of a cerebral infarction with neurological deficit
Inclusion Criteria
Inclusion Criteria:
1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4
1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
2. External ventricular drain in place
3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
4. WFNS grade 2, 3, or 4
Gender
All
Gender Based
false
Keywords
Aneurysm, Ruptured
Nimodipine
Subarachnoid Hemorrhage
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT02790632
Org Class
Industry
Org Full Name
Edge Therapeutics Inc
Org Study Id
EG-01-1962-03
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
Outcome Measure
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
Outcome Time Frame
90 Days
Secondary Outcomes
Outcome Description
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90
Outcome Time Frame
90 Days
Outcome Measure
Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rishi Malhotra
Investigator Email
rmalhotr@montefiore.org
Investigator Phone