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

Description

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

Study Start Date

July, 01 2016

Estimated Completion Date

August 2018

Interventions

  • Drug: EG-1962 (nimodipine microparticles)
  • Drug: Enteral Nimodipine

Study ID

Edge Therapeutics Inc -- EG-01-1962-03

Status

Recruiting

Trial ID

NCT02790632

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

374

Sponsor

Edge Therapeutics Inc

Inclusion Criteria

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

Exclusion Criteria

    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 a cerebral infarction with neurological deficit

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (122)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Yale New Haven Hospital YNHH - New Haven, Connecticut 119.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Yale New Haven Hospital YNHH - New Haven, Connecticut 119.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Yale New Haven Hospital YNHH - New Haven, Connecticut 119.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
North Shore University Hospital - Manhasset, New York 172.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
North Shore University Hospital - Manhasset, New York 172.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
North Shore University Hospital - Manhasset, New York 172.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Montefiore Medical Center - The Bronx, New York 176.6 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Montefiore Medical Center - The Bronx, New York 176.6 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Montefiore Medical Center - The Bronx, New York 176.6 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Lenox Hill Hospital - New York, New York 187.1 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Lenox Hill Hospital - New York, New York 187.1 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Lenox Hill Hospital - New York, New York 187.1 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Robert Wood Johnson University Hospital - New Brunswick, New Jersey 217.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Robert Wood Johnson University Hospital - New Brunswick, New Jersey 217.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Robert Wood Johnson University Hospital - New Brunswick, New Jersey 217.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Jefferson Hospital for Neuroscience - Philadelphia, Pennsylvania 269.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Jefferson Hospital for Neuroscience - Philadelphia, Pennsylvania 269.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Jefferson Hospital for Neuroscience - Philadelphia, Pennsylvania 269.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Rochester Medical Center - Rochester, New York 335.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Rochester Medical Center - Rochester, New York 335.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Rochester Medical Center - Rochester, New York 335.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Maryland Medical Systems - Baltimore, Maryland 358.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Maryland Medical Systems - Baltimore, Maryland 358.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Maryland Medical Systems - Baltimore, Maryland 358.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Inova Fairfax Medical Campus - Falls Church, Virginia 401.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Inova Fairfax Medical Campus - Falls Church, Virginia 401.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Inova Fairfax Medical Campus - Falls Church, Virginia 401.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
VCU Medical Center - Richmond, Virginia 473.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
VCU Medical Center - Richmond, Virginia 473.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
VCU Medical Center - Richmond, Virginia 473.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania 478.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania 478.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania 478.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Allegheny General Hospital - Pittsburgh, Pennsylvania 480.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Allegheny General Hospital - Pittsburgh, Pennsylvania 480.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Allegheny General Hospital - Pittsburgh, Pennsylvania 480.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University Hospitals Case Medical Center - Cleveland, Ohio 544.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Duke University Medical Pavilion - Durham, North Carolina 609.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Duke University Medical Pavilion - Durham, North Carolina 609.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Duke University Medical Pavilion - Durham, North Carolina 609.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UNC Hospitals Neuroscience Intensive Care Unit - Chapel Hill, North Carolina 616.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UNC Hospitals Neuroscience Intensive Care Unit - Chapel Hill, North Carolina 616.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UNC Hospitals Neuroscience Intensive Care Unit - Chapel Hill, North Carolina 616.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
The Ohio State University Wexner Medical Center - Columbus, Ohio 641.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Kentucky Medical Center - Lexington, Kentucky 769.1 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Medical University of South Carolina - Charleston Air Force Base, South Carolina 821.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Medical University of South Carolina - Charleston Air Force Base, South Carolina 821.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Medical University of South Carolina - Charleston Air Force Base, South Carolina 821.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Louisville Hospital - Louisville, Kentucky 823.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Louisville Hospital - Louisville, Kentucky 823.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Louisville Hospital - Louisville, Kentucky 823.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Rush University Medical Center - Chicago, Illinois 851.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Rush University Medical Center - Chicago, Illinois 851.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Rush University Medical Center - Chicago, Illinois 851.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Mayo Clinic Florida - Jacksonville, Florida 1,015.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Mayo Clinic Florida - Jacksonville, Florida 1,015.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Mayo Clinic Florida - Jacksonville, Florida 1,015.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Baptist Medical CenterLyerly Neurosurgery - Jacksonville, Florida 1,020.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Baptist Medical CenterLyerly Neurosurgery - Jacksonville, Florida 1,020.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Baptist Medical CenterLyerly Neurosurgery - Jacksonville, Florida 1,020.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Alabama at Birmingham Hospital - Birmingham, Alabama 1,051.7 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UF Health Shands Florida - Gainesville, Florida 1,081.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UF Health Shands Florida - Gainesville, Florida 1,081.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UF Health Shands Florida - Gainesville, Florida 1,081.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Tallahassee Neurological Clinic - Tallahassee, Florida 1,096.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Tallahassee Neurological Clinic - Tallahassee, Florida 1,096.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Tallahassee Neurological Clinic - Tallahassee, Florida 1,096.9 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Semmes Murphey Neurological Clinic - Memphis, Tennessee 1,127.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Semmes Murphey Neurological Clinic - Memphis, Tennessee 1,127.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Semmes Murphey Neurological Clinic - Memphis, Tennessee 1,127.5 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of New Mexico Hospital - Albuquerque, New Mexico 1,968.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of New Mexico Hospital - Albuquerque, New Mexico 1,968.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of New Mexico Hospital - Albuquerque, New Mexico 1,968.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Dignity Health St Josephs Hospital and Medical Center - Phoenix, Arizona 2,297.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Dignity Health St Josephs Hospital and Medical Center - Phoenix, Arizona 2,297.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Dignity Health St Josephs Hospital and Medical Center - Phoenix, Arizona 2,297.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of Washington Harborview Medical Center - Seattle, Washington 2,489.6 miles None None None
University of Washington Harborview Medical Center - Seattle, Washington 2,489.6 miles None None None
University of Washington Harborview Medical Center - Seattle, Washington 2,489.6 miles None None None
Oregon Health and Science University - Portland, Oregon 2,538.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Oregon Health and Science University - Portland, Oregon 2,538.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Oregon Health and Science University - Portland, Oregon 2,538.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Providence St Vincent Medical Center - Portland, Oregon 2,542.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Providence St Vincent Medical Center - Portland, Oregon 2,542.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Providence St Vincent Medical Center - Portland, Oregon 2,542.0 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of California San FranciscoFresno - Fresno, California 2,593.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of California San FranciscoFresno - Fresno, California 2,593.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
University of California San FranciscoFresno - Fresno, California 2,593.3 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
Keck Hospital of USC - Los Angeles, California 2,593.7 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
David Geffen School of Medicine at UCLA - Los Angeles, California 2,605.2 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UCSF - San Francisco, California 2,699.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UCSF - San Francisco, California 2,699.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com
UCSF - San Francisco, California 2,699.8 miles Edge Therapeutics None clinicaltrials@edgetherapeutics.com

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