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)] - Hänggi, Daniel; Etminan, Nima; Mayer, Stephan A.; Aldrich, E. Francois; Diringer, Michael N.; Schmutzhard, Erich; Faleck, Herbert J.; Ng, David; Saville, Benjamin R.; Macdonald, R. Loch (Neurocritical care, 2019)
Keywords: Adult; Aged; Calcium Channel Blockers - administration & dosage; Calcium Channel Blockers - adverse effects; Calcium Channel Blockers - pharmacology; Cerebrospinal fluid; Chromatography; Clinical trials; Clinical Trials, Phase III as Topic; Critical Care Medicine; Delayed-Action Preparations; Double-Blind Method; Female; Glasgow Outcome Scale; Hemorrhage; Humans; Hypotension; Infusions, Intraventricular; Intensive; Internal Medicine; Ischemia; Male; Medicine; Medicine & Public Health; Middle Aged; Multicenter Studies as Topic; NCT; NCT02790632; Neurology; Nimodipine - administration & dosage; Nimodipine - adverse effects; Nimodipine - pharmacology; Original Article; Outcome Assessment, Health Care; Patients; Pharmacokinetics; Randomized Controlled Trials as Topic; Standard of Care; Stroke; Subarachnoid Hemorrhage - drug therapy; Toxicity; Canada; Czech Republic; United States--US; North America; Finland; Cerebral aneurysm; Delayed cerebral ischemia; Extended release; Nimodipine; aSAH; Subarachnoid hemorrhage; Clinical trial