Science Times: Intraventricular Nimodipine for Aneurysmal Subarachnoid Hemorrhage: Results of the NEWTON Phase 1/2a Study

Nimodipine, a calcium channel antagonist that selectively dilates cerebral arteries, has been shown to improve clinical outcomes in aneurysmal subarachnoid hemorrhage (aSAH) patients.1 Enteral delivery of nimodipine is the standard of care and systemic hypotension is a common and serious side effect.23 In an effort to avoid this toxicity, researchers developed a novel compound called EG-1962, which consists of a nimodipine suspension within a biodegradable polymer that is administered as a one-time intraventricular injection and releases nimodipine into the intraventricular and subarachnoid spaces for at least 21 d. The Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage (NEWTON) investigators performed a randomized, open-label, phase 1/2a clinical trial of EG-1962 in aSAH patients.4

The authors studied aSAH patients that had a ventriculostomy placed as a routine component of their care. They randomized patients to receive either nimodipine delivered via the standard enteral route (18 patients) or the experimental compound EG-1962 delivered intraventricularly (54 patients). They used a dose-escalation study design to determine the safety and tolerability of the experimental compound. And they studied the characteristics of participating patients to compare the clinical outcomes of patients in the standard and experimental cohorts.

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