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Eligibility
for people ages 18 years to 75 years
Location
at Fresno, California and other locations
Dates
study started
estimated completion:

Description

Summary

This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

Official Title

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

Keywords

Subarachnoid Hemorrhage, Aneurysmal Aneurysm, Ruptured Nimodipine Subarachnoid Hemorrhage

Eligibility

You can join if…

Open to people ages 18 years to 75 years

  1. Ruptured saccular aneurysm confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
  2. External ventricular drain in place
  3. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
  4. WFNS grade 2, 3, or 4

You CAN'T join if...

  1. 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
  2. Angiographic vasospasm prior to randomization
  3. Evidence of a cerebral infarction with neurological deficit

Locations

  • Keck Hospital of USC accepting new patients
    Los Angeles, California, 90033, USA
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, USA
  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles, California, 90095, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edge Therapeutics Inc
ID
NCT02790632
Phase
Phase 3
Study Type
Interventional
Last Updated
March 2017
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