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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.

Official Title

Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral 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 18–75

  1. Ruptured saccular aneurysm repaired by neurosurgical clipping
  2. Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
  3. WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair

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 cerebral infarction with neurological deficit

Locations

  • Dignity Health; St. Joseph's Hospital and Medical Center accepting new patients
    Phoenix, Arizona, 85013, United States
  • University of Alberta Hospital/Mackenzie Health Sciences Centre accepting new patients
    Edmonton, Alberta, T6G 2B7, Canada
  • University of Maryland Medical Systems accepting new patients
    Baltimore, Maryland, 21201, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edge Therapeutics Inc
ID
NCT02893826
Phase
Phase 1
Lead Scientist
Nerissa Ko
Study Type
Interventional
Last Updated
January 1, 2017
I’m interested in this study!