Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Satefy Study Comparing EG-1962 to Standard Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorraghe

This is a Phase 3 multicenter, controlled, open-label, and randomized, study.

Primary objective: To compare the efficacy of intraventricular EG-1962 to standard of care oral nimodipine in subjects with aSAH.

Secondary objective: To determine the safety of intraventricular EG-1962 compared to standard of care oral nimodipine in subjects with aSAH.

Study Population: Male or female subjects between the ages of 18 to 75 years, inclusive, with a ruptured saccular aneurysm confirmed by angiography (CTA, MRA or catheter) and treated by neurosurgical clipping or endovascular coiling will be considered for randomization into this study. Additionally, subjects must have an external ventricular drain (EVD) in place and a WFNS grade of 2 – 4 after aneurysm repair but prior to randomization.

Study Design: This is a phase 3, multicenter, randomized, double-blind, double-dummy, placebocontrolled, parallel-group, efficacy and safety study. All subjects will receive both intraventricular investigational product (IP) (EG-1962 or normal saline) and oral IP (nimodipine capsules/tablets or placebo capsules/tablets identical in appearance to oral nimodipine). The study will consist of two phases: Pre-randomization and Randomization. The Randomization Phase includes two periods: Treatment Period and Follow-up Observation Period

Principal Investigator(s)