Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

Official Title
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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

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 confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling External ventricular drain in place Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale WFNS grade 2, 3, or 4 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 a 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG-1962 Group<br>1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg Up to 21 days of placebo capsules/tablets | Drug: EG-1962 (nimodipine microparticles)<br>* Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days<br>|
| Active Comparator: Enteral Nimodipine Group<br>1 dose of intraventricular normal saline Up to 21 days of oral nimodipine capsules/tablets | Drug: Enteral Nimodipine<br>* Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] | Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90 | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] | Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90 | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aneurysm, Ruptured, Nimodipine, Subarachnoid Hemorrhage