Randomized, Open-Label, International, Multi-center Study Comparing
EG-1962 To Oral Nimodipine
EG-1962 is a novel polymeric nimodipine microparticle that is administered directly into the brain ventricles as a single dose and releases the drug at the site of brain injury over 21-days. EG-1962 is being developed to improve patient outcome by preventing DCI, a life-threatening complication of SAH that typically results from a ruptured brain aneurysm or traumatic brain injury (TBI).
“DCI is a very serious, yet potentially preventable complication of subarachnoid hemorrhage,” said
“We are excited to announce the start of the NEWTON study and to treat patients whose lives could be improved with this potential new therapy,” said Dr.
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study will enroll up to 96 patients in approximately 20 centers internationally. The study will evaluate safety, tolerability, pharmacokinetics, and exploratory efficacy endpoints compared to oral nimodipine in patients with ruptured brain aneurysms. The first part of the study is a dose exploration phase of up to six dosing level cohorts with up to 12 patients per cohort, randomized at a ratio of 3 to 1 to receive either single dose EG-1962 or oral nimodipine. The primary objective of the dose - exploration phase is to establish the dose of EG-1962 to take forward into the next study. The second part of the study is a potential expansion phase allowing for treatment of additional patients to further evaluate the selected dose of EG-1962. Completion of the study is expected in 2014.1