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

Authors

• Andrew P Carlson
• Daniel Hänggi
• George K Wong
• Nima Etminan
• Stephan A Mayer
• François Aldrich
• Michael N Diringer
• Erich Schmutzhard
• Herbert J Faleck
• David Ng
• Benjamin R Saville
• Thomas Bleck
• Robert Grubb
• Michael Miller
• Jose I Suarez
• Howard M Proskin
• R Loch Macdonald

Publication/Presentation Date

4-1-2020

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 follow-up of all subjects, the proportion with favorable outcome on the extended Glasgow outcome scale was 45% (65/144) in the EG-1962 and 42% (62/145) in the placebo group (risk ratio, 1.01 [95% CI, 0.83-1.22],

Volume

51

Issue

4

First Page

1142

Last Page

1149

ISSN

1524-4628

Published In/Presented At

Carlson, A. P., Hänggi, D., Wong, G. K., Etminan, N., Mayer, S. A., Aldrich, F., Diringer, M. N., Schmutzhard, E., Faleck, H. J., Ng, D., Saville, B. R., Bleck, T., Grubb, R., Jr, Miller, M., Suarez, J. I., Proskin, H. M., Macdonald, R. L., & NEWTON Investigators (2020). Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage. Stroke, 51(4), 1142–1149. https://doi.org/10.1161/STROKEAHA.119.027396

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

32138631

Department(s)

Administration and Leadership

Document Type

Article