Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Interventions
- Drug: EG-1962 (nimodipine microparticles)
- Registration Number
- NCT02790632
- Lead Sponsor
- Edge Therapeutics Inc
- Brief Summary
This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 374
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enteral Nimodipine Group Enteral Nimodipine * 1 dose of intraventricular normal saline * Up to 21 days of oral nimodipine capsules/tablets EG-1962 Group EG-1962 (nimodipine microparticles) * 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg * Up to 21 days of placebo capsules/tablets
- Primary Outcome Measures
Name Time Method Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] 90 Days Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
- Secondary Outcome Measures
Name Time Method Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] 90 Days Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90
Trial Locations
- Locations (79)
North Shore University Hospital
๐บ๐ธManhasset, New York, United States
UCSF
๐บ๐ธSan Francisco, California, United States
Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
๐ฆ๐นInnsbruck, Austria
University of Alberta Hospital/Mackenzie Health Sciences Centre
๐จ๐ฆEdmonton, Alberta, Canada
Robert Wood Johnson University Hospital
๐บ๐ธNew Brunswick, New Jersey, United States
Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
๐จ๐ฆMontrรฉal, Quebec, Canada
Royal University Hospital
๐จ๐ฆSaskatoon, Saskatchewan, Canada
Medical University of South Carolina
๐บ๐ธCharleston Air Force Base, South Carolina, United States
Rambam Health Care Center
๐ฎ๐ฑHaifa, Israel
Semmes Murphey Neurological Clinic
๐บ๐ธMemphis, Tennessee, United States
Vancouver General Hospital
๐จ๐ฆVancouver, British Columbia, Canada
Mayo Clinic Florida
๐บ๐ธJacksonville, Florida, United States
Keck Hospital of USC
๐บ๐ธLos Angeles, California, United States
David Geffen School of Medicine at UCLA
๐บ๐ธLos Angeles, California, United States
Dignity Health; St. Joseph's Hospital and Medical Center
๐บ๐ธPhoenix, Arizona, United States
Cedars-Sinai Medical Center
๐บ๐ธLos Angeles, California, United States
Northwestern Memorial Hospital
๐บ๐ธChicago, Illinois, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Hackensack University Medical Center
๐บ๐ธHackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
๐บ๐ธNew York, New York, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
UNC Hospitals Neuroscience Intensive Care Unit
๐บ๐ธChapel Hill, North Carolina, United States
Hadassah Hebrew University Medical Center
๐ฎ๐ฑJerusalem, Israel
Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
๐ฉ๐ชWรผrzburg, Germany
National Neuroscience Institute
๐ธ๐ฌSingapore, Singapore
University of Alabama at Birmingham Hospital
๐บ๐ธBirmingham, Alabama, United States
University of California, San Francisco-Fresno
๐บ๐ธFresno, California, United States
Yale New Haven Hospital (YNHH)
๐บ๐ธNew Haven, Connecticut, United States
Baptist Medical Center/Lyerly Neurosurgery
๐บ๐ธJacksonville, Florida, United States
Tallahassee Neurological Clinic
๐บ๐ธTallahassee, Florida, United States
University of Illinois Hospital and Health Sciences System
๐บ๐ธChicago, Illinois, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
University of Kentucky Medical Center
๐บ๐ธLexington, Kentucky, United States
Henry Ford Hospital
๐บ๐ธDetroit, Michigan, United States
University of Louisville Hospital
๐บ๐ธLouisville, Kentucky, United States
University of New Mexico Hospital
๐บ๐ธAlbuquerque, New Mexico, United States
Lenox Hill Hospital
๐บ๐ธNew York, New York, United States
Duke University Medical Pavilion
๐บ๐ธDurham, North Carolina, United States
The Ohio State University Wexner Medical Center
๐บ๐ธColumbus, Ohio, United States
Providence St. Vincent Medical Center
๐บ๐ธPortland, Oregon, United States
University Hospitals Case Medical Center
๐บ๐ธCleveland, Ohio, United States
Oregon Health and Science University
๐บ๐ธPortland, Oregon, United States
Hospital of the University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Allegheny General Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
Jefferson Hospital for Neuroscience
๐บ๐ธPhiladelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
Inova Fairfax Medical Campus
๐บ๐ธFalls Church, Virginia, United States
VCU Medical Center
๐บ๐ธRichmond, Virginia, United States
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, New South Wales, Australia
Nepean Hospital
๐ฆ๐บKingswood, New South Wales, Australia
University of Washington, Harborview Medical Center
๐บ๐ธSeattle, Washington, United States
Royal Adelaide Hospital
๐ฆ๐บAdelaide, Australia
Faculty Hospital Hradec Kralove
๐จ๐ฟHradec Krรกlovรฉ, Hradec Kralov, Czechia
St. Michael's Hospital
๐จ๐ฆToronto, Ontario, Canada
Military University Hospital Prague
๐จ๐ฟPrague, Czechia
Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
๐ฉ๐ชBerlin, Germany
Tampere University Hospital
๐ซ๐ฎTampere, Pirkanmaa, Finland
Faculty Hospital Ostrava
๐จ๐ฟOstrava, Czechia
Helsinki University Hospital
๐ซ๐ฎHelsinki, Finland
Faculty Hospital Brno
๐จ๐ฟBrno, South Moravian Region, Czechia
Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
๐ฉ๐ชErlangen, Germany
Neurochirurgische Klinik der Universitรคt Heidelberg
๐ฉ๐ชHeidelberg, Germany
Klinik fรผr Neurochirurgie des Universitรคtsklinikum Essen
๐ฉ๐ชEssen, Germany
Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universitรคt Heidelberg
๐ฉ๐ชMannheim, Germany
Klinik fรผr Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitรคtsklinikum Frankfurt am Main
๐ฉ๐ชFrankfurt am Main, Germany
Universitรคtsklinikum Hamburg Eppendorf, Klinik und Poliklinik fรผr Neurochirurgie, Neues Klinikum
๐ฉ๐ชHamburg, Germany
Zentrum fur Neurochirurgie der Uniklinik Koln
๐ฉ๐ชKรถln, Germany
Klinik und Poliklinik fรผr Neurochirurgie des Universitatsklinikum Leipzig
๐ฉ๐ชLeipzig, Germany
Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
๐ฉ๐ชMunchen, Germany
Prince of Wales Hospital
๐ญ๐ฐNew Kowloon, Hong Kong
Rabin Medical Center
๐ฎ๐ฑPetaแบ Tiqwa, Petah-Tikva, Israel
Queen Mary Hospital
๐ญ๐ฐHong Kong, Hong Kong
Sheba Medical Center
๐ฎ๐ฑRamat Gan, Israel
Auckland City Hospital
๐ณ๐ฟAuckland, New Zealand
University of Maryland Medical Systems
๐บ๐ธBaltimore, Maryland, United States
UF Health Shands Florida
๐บ๐ธGainesville, Florida, United States
Montefiore Medical Center
๐บ๐ธBronx, New York, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States