Clinical Trial Protocol: 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 [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)

Neurocritical Care
Daniel HänggiNEWTON Investigators

Abstract

Nimodipine is the only drug approved in the treatment of aneurysmal subarachnoid hemorrhage (aSAH) in many countries. EG-1962, a product developed using the Precisa™ platform, is an extended-release microparticle formulation of nimodipine that can be administered intraventricularly or intracisternally. It was developed to test the hypothesis that delivering higher concentrations of extended-release nimodipine directly to the cerebrospinal fluid would provide superior efficacy compared to systemic administration. A Phase 1/2a multicenter, controlled, randomized, open-label, dose-escalation study determined the maximum tolerated dose and supported the safety and tolerability of EG-1962 in patients with aSAH. EG-1962, 600 mg, was selected for a pivotal, Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group efficacy, and safety study comparing it to standard of care oral nimodipine in adults with aSAH. Key inclusion criteria are patients with a ruptured saccular aneurysm repaired by clipping or coiling, World Federation of Neurological Surgeons grade 2-4, and modified Fisher score of > 1. Patients must have an external ventricular drain as part of standard of care. Patients are randomized to receive intr...Continue Reading

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Citations

Apr 20, 2018·Stroke; a Journal of Cerebral Circulation·Julie BernhardtMichael Tymianski
Feb 23, 2020·Critical Care Nursing Quarterly·Keaton S SmetanaCasey C May
Mar 7, 2020·Stroke; a Journal of Cerebral Circulation·Andrew P CarlsonUNKNOWN NEWTON Investigators
Oct 5, 2019·CNS Neuroscience & Therapeutics·Badih J DaouAditya S Pandey
Mar 7, 2020·Advanced Drug Delivery Reviews·M J FowlerR W Sirianni
Mar 12, 2021·Advanced Drug Delivery Reviews·Ghazal Naseri KouzehgaraniDidier R Lefebvre

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