Summary

for people ages 18–75 (full criteria)
at Fresno, California and other locations
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 Hemorrhage

Eligibility

You can join if…

Open to people ages 18–75

  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

  • University of California, San Francisco-Fresno
    Fresno, California, 93701, United States
  • UCSF
    San Francisco, California, 94143, United States
  • David Geffen School of Medicine at UCLA
    Los Angeles, California, 90095, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, 90048, United States
  • Keck Hospital of USC
    Los Angeles, California, 90033, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edge Therapeutics Inc
ID
NCT02790632
Phase
Phase 3
Study Type
Interventional
Last Updated
April 4, 2018