Safety/Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With aSAH

Stopped early · Phase 1

Conditions studied: Subarachnoid Hemorrhage, Aneurysmal

In brief

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

Key facts

Study ID

NCT02893826

Run by

Edge Therapeutics Inc

People needed

6

Starts

2016-09-01

Expected to finish

2018-03-01

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ruptured saccular aneurysm repaired by neurosurgical clipping
• Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
• 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 may not qualify if…

• 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
• Angiographic vasospasm prior to randomization
• Evidence of cerebral infarction with neurological deficit

Where it is running

• Dignity Health; St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of California San Francisco — San Francisco, California, United States
• University of Maryland Medical Systems — Baltimore, Maryland, United States
• University of Alberta Hospital/Mackenzie Health Sciences Centre — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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