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The NEWTON 2 Trial

Clinical Trial Title: 
A 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.
Clinical Trial Protocol ID: 
15100502
Clinical Trial Investigator Name: 
George Lopez, MD
Clinical Trial Protocol Description: 

Primary objective: To compare the efficacy of intraventricular EG-1962 to standard of care oral nimodipine in subjects with aSAH.

Secondary objective: To determine the safety of intraventricular EG-1962 compared to standard of care oral nimodipine in subjects with aSAH.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling.
  • Have an external ventricular drain in place.
  • Have subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale.
  • Have WFNS grade 2, 3, or 4.

You will be excluded from the study if any of the following criteria apply to you:

  • Have major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm.
  • Have angiographic vasospasm prior to randomization.
  • Have evidence of a cerebral infarction with neurological deficit.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Stroke and Cerebrovascular Disease
Contact Phone: 
(312) 942-6731
Contact Name: 
Rebecca Holtz