Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
NCT ID: NCT02790632
Last Updated: 2018-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
374 participants
INTERVENTIONAL
2016-07-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EG-1962 Group
* 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg
* Up to 21 days of placebo capsules/tablets
EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Enteral Nimodipine Group
* 1 dose of intraventricular normal saline
* Up to 21 days of oral nimodipine capsules/tablets
Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
Interventions
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EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
Eligibility Criteria
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Inclusion Criteria
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
2. Angiographic vasospasm prior to randomization
3. Evidence of a cerebral infarction with neurological deficit
18 Years
75 Years
ALL
No
Sponsors
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Edge Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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R. Loch Macdonald, MD, PhD
Role: STUDY_CHAIR
Edge Therapeutics Inc
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
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
North Shore University Hospital
Manhasset, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Hospitals Neuroscience Intensive Care Unit
Chapel Hill, North Carolina, United States
Duke University Medical Pavilion
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston Air Force Base, South Carolina, United States
Semmes Murphey Neurological Clinic
Memphis, Tennessee, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
University of Washington, Harborview Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
Innsbruck, , Austria
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Faculty Hospital Hradec Kralove
Hradec Králové, Hradec Kralov, Czechia
Faculty Hospital Brno
Brno, South Moravian, Czechia
Faculty Hospital Ostrava
Ostrava, , Czechia
Military University Hospital Prague
Prague, , Czechia
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Helsinki University Hospital
Helsinki, , Finland
Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
Berlin, , Germany
Zentrum fur Neurochirurgie der Uniklinik Koln
Cologne, , Germany
Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
Erlangen, , Germany
Klinik für Neurochirurgie des Universitätsklinikum Essen
Essen, , Germany
Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main
Frankfurt am Main, , Germany
Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum
Hamburg, , Germany
Neurochirurgische Klinik der Universität Heidelberg
Heidelberg, , Germany
Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig
Leipzig, , Germany
Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg
Mannheim, , Germany
Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
München, , Germany
Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
Würzburg, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
New Kowloon, , Hong Kong
Rabin Medical Center
Petah Tikva, Petah-Tikva, Israel
Rambam Health Care Center
Haifa, , Israel
Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Auckland City Hospital
Auckland, , New Zealand
National Neuroscience Institute
Singapore, , Singapore
Countries
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References
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Carlson AP, Hanggi D, Wong GK, Etminan N, Mayer SA, Aldrich F, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Bleck T, Grubb R Jr, Miller M, Suarez JI, Proskin HM, Macdonald RL; NEWTON Investigators. Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage. Stroke. 2020 Apr;51(4):1142-1149. doi: 10.1161/STROKEAHA.119.027396. Epub 2020 Mar 6.
Hanggi D, Etminan N, Mayer SA, Aldrich EF, Diringer MN, Schmutzhard E, Faleck HJ, Ng D, Saville BR, Macdonald RL; NEWTON Investigators. Clinical Trial Protocol: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage [NEWTON-2 (Nimodipine Microparticles to Enhance Recovery While Reducing TOxicity After SubarachNoid Hemorrhage)]. Neurocrit Care. 2019 Feb;30(1):88-97. doi: 10.1007/s12028-018-0575-z.
Other Identifiers
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EG-01-1962-03
Identifier Type: -
Identifier Source: org_study_id
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