Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH

Study Overview
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Brief Summary
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Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.

Official Title
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Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Drug: EG-1962 (nimodipine microparticles)
* Drug: Enteral Nimodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ruptured saccular aneurysm repaired by neurosurgical clipping Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale 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: 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 Angiographic vasospasm prior to randomization Evidence of cerebral infarction with neurological deficit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG-1962 Group<br>1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg | Drug: EG-1962 (nimodipine microparticles)<br> <br> * Other names: Single intracisternal adminstration;|
| Active Comparator: Enteral Nimodipine Group<br>Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization) | Drug: Enteral Nimodipine<br> <br> * Other names: Administered for up to 21 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aneurysm, Ruptured, nimodipine, subarachnoid hemorrhage