Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Subarachnoid Hemorrhage, Aneurysmal

In brief

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

Key facts

Study ID

NCT02790632

Run by

Edge Therapeutics Inc

People needed

374

Starts

2016-07-01

Expected to finish

2018-06-01

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

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 a 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-Fresno — Fresno, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• Yale New Haven Hospital (YNHH) — New Haven, Connecticut, United States
• UF Health Shands Florida — Gainesville, Florida, United States
• Baptist Medical Center/Lyerly Neurosurgery — Jacksonville, Florida, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Tallahassee Neurological Clinic — Tallahassee, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• University of Maryland Medical Systems — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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