Blog Viewer

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 (Nimo

By Currents Editor posted 02-11-2019 14:01

  

By Daniel Hänggi, Nima Etminan, Stephan A. Mayer, E. Francois Aldrich, Michael N. Diringer, Erich Schmutzhard, Herbert J. Faleck, David Ng, Benjamin R. Saville, R. Loch Macdonald, for the NEWTON Investigators

Background

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.

Results

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 intraventricular investigational product (EG-1962 or NaCl solution) and an oral placebo or oral nimodipine in the approved dose regimen (active control) within 48 h of aSAH. The primary objective is to determine the efficacy of EG-1962 compared to oral nimodipine.

Conclusions

The primary endpoint is the proportion of subjects with favorable outcome (6–8) on the Extended Glasgow Outcome Scale assessed 90 days after aSAH. The secondary endpoint is the proportion of subjects with favorable outcome on the Montreal Cognitive Assessment 90 days after aSAH. Data on safety, rescue therapy, delayed cerebral infarction, and health economics will be collected.

Trail registration NCT02790632.

Read more

#NCJ

FURTHER READING
By Roy Poblete, MD, David Seder, MD, Gene Sung, MD     Since the first Emergency Neurologic Life Support (ENLS) course, there has always been a great deal of interest in developing an advanced learning follow-up course. The Neurocritical Care Society is now proud to present the brand-new ...
The Currents Editorial Board is seeking Stories of Hope submissions for 2020. Stories of Hope tells the stories of patients who have fought their way to recovery and the experiences of their family and/or medical providers. By sharing these stories, we remind each other of what we are all working ...
By Pouya Alexander Ameli, MD, MS Neurocritical Care Fellow, Emory University Chair-Elect, Trainee Section   Naomi Niznick, MD PGY3 Neurology Resident, The Ottawa Hospital Trainee Section Leadership Committee     In Homer’s The Odyssey , Odysseus asks for his friend “Mentor” to watch ...