Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage
Brief summary
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
Interventions
Sponsors
Edge Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ruptured saccular aneurysm repaired by neurosurgical clipping 2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale 3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
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 cerebral infarction with neurological deficit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | 90 Days |
| Proportion of subjects with delayed cerebral infarctions present on CT at Day 30 | 30 Days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to last plasma concentration |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 14 |
| Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10) | At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 10 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Extended Glasgow Outcome Scale (GOSE) | Day 90 | Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90 |
| Montreal Cognitive Assessment (MoCA) | Day 90 | Proportion of subjects with a favorable outcome measured on the Montreal Cognitive Assessment (MoCA) at Day 90 |
Countries
Canada, United States
Outcome results
None listed