Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage

Stroke; a Journal of Cerebral Circulation
Andrew P CarlsonNEWTON Investigators

Abstract

Background and Purpose- EG-1962 is a sustained release formulation of nimodipine administered via external ventricular drain in patients with aneurysmal subarachnoid hemorrhage. A randomized, open-label, phase 1/2a, dose-escalation study provided impetus for this study to evaluate efficacy and safety of a single intraventricular 600 mg dose of EG-1962 to patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral nimodipine. Methods- Subjects were World Federation of Neurological Surgeons grades 2-4, modified Fisher grades 2-4 and had an external ventricular drain inserted as part of standard of care. The primary end point was the proportion of subjects with favorable outcome at day 90 after aneurysmal subarachnoid hemorrhage (extended Glasgow outcome scale 6-8). The proportion of subjects with favorable outcome at day 90 on the Montreal cognitive assessment, as well as the incidence of delayed cerebral ischemia and infarction, use of rescue therapy and safety were evaluated. Results- The study was halted by the independent data monitoring board after planned interim analysis of 210 subjects (289 randomized) with day 90 outcome found the study was unlikely to achieve its primary end point. After day 90...Continue Reading

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Citations

Sep 10, 2020·Drugs in R&D·Sherif Hanafy MahmoudFadumo Ahmed Isse
Oct 21, 2020·Translational Stroke Research·Sean N NeifertR Loch Macdonald
Apr 8, 2021·Expert Opinion on Pharmacotherapy·Tatsuya Maruhashi, Yukihito Higashi
Jun 12, 2021·Stroke; a Journal of Cerebral Circulation·Ruchira M Jha, Kevin N Sheth
Jul 31, 2021·Journal of the American Heart Association·William S DoddNohra Chalouhi
Aug 9, 2021·Journal of Stroke and Cerebrovascular Diseases : the Official Journal of National Stroke Association·Feras AkbikOfer Sadan

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