Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in
the treatment of aneurysmal subarachnoid hemorrhage.
Drug: EG-1962 (nimodipine microparticles)
Drug: Enteral Nimodipine
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Full eligibility criteria for NCT02893826
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02893826
United States (3)
St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
University of California San Francisco
San Francisco, California, United States, 94143
University of Maryland Medical Systems
Baltimore, Maryland, United States, 21201
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
View full eligibility
Tris trial is registered with FDA with number: NCT02893826. The sponsor of the trial is Edge Therapeutics Inc and it is looking for 6 volunteers for the current phase.
Official trial title: Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
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