Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
Aneurysm, Ruptured, Nimodipine, Subarachnoid Hemorrhage
Brief summary
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
Interventions
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
Sponsors
Edge Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] | 90 Days | Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] | 90 Days | Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 90 Days | Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine |
| Delayed Cerebral Infarction | 30 Days | Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30 |
Countries
Australia, Austria, Canada, Czechia, Finland, Germany, Hong Kong, Israel, New Zealand, Singapore, United States
Outcome results
None listed