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Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage (NEWTON2)

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ClinicalTrials.gov Identifier: NCT02790632
Recruitment Status : Active, not recruiting
First Posted : June 6, 2016
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Edge Therapeutics Inc

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

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Drug: EG-1962 (nimodipine microparticles) Drug: Enteral Nimodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Nimodipine

Arm Intervention/treatment
Experimental: EG-1962 Group
  • 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg
  • Up to 21 days of placebo capsules/tablets
Drug: EG-1962 (nimodipine microparticles)
Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days

Active Comparator: Enteral Nimodipine Group
  • 1 dose of intraventricular normal saline
  • Up to 21 days of oral nimodipine capsules/tablets
Drug: Enteral Nimodipine
Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD




Primary Outcome Measures :
  1. Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint] [ Time Frame: 90 Days ]
    Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90


Secondary Outcome Measures :
  1. Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint] [ Time Frame: 90 Days ]
    Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 90 Days ]
    Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine

  2. Delayed Cerebral Infarction [ Time Frame: 30 Days ]
    Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790632


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Locations
United States, Alabama
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35233
United States, Arizona
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
University of California, San Francisco-Fresno
Fresno, California, United States, 93701
Keck Hospital of USC
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
UCSF
San Francisco, California, United States, 94143
United States, Connecticut
Yale New Haven Hospital (YNHH)
New Haven, Connecticut, United States, 06510
United States, Florida
UF Health Shands Florida
Gainesville, Florida, United States, 32610
Baptist Medical Center/Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612-7232
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Medical Systems
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
North Shore University Hospital
Manhasset, New York, United States, 11030
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Lenox Hill Hospital
New York, New York, United States, 10075
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
UNC Hospitals Neuroscience Intensive Care Unit
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Pavilion
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston Air Force Base, South Carolina, United States, 29425
United States, Tennessee
Semmes Murphey Neurological Clinic
Memphis, Tennessee, United States, 38120
United States, Virginia
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
VCU Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington, Harborview Medical Center
Seattle, Washington, United States, 98104
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
Kingswood, New South Wales, Australia, 02747
Australia
Royal Adelaide Hospital
Adelaide, Australia, 5000
Austria
Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
Innsbruck, Austria, 06020
Canada, Alberta
University of Alberta Hospital/Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
Montréal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czechia
Faculty Hospital Hradec Kralove
Hradec Králové, Hradec Kralov, Czechia, 50005
Faculty Hospital Brno
Brno, South Moravian Region, Czechia, 62500
Faculty Hospital Ostrava
Ostrava, Czechia, 708 52
Military University Hospital Prague
Prague, Czechia, 16902
Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33521
Helsinki University Hospital
Helsinki, Finland, 00260
Germany
Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
Berlin, Germany, 10117
Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
Erlangen, Germany, 91054
Klinik für Neurochirurgie des Universitätsklinikum Essen
Essen, Germany, 45147
Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main
Frankfurt am Main, Germany, 60528
Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum
Hamburg, Germany, 20246
Neurochirurgische Klinik der Universität Heidelberg
Heidelberg, Germany, 69120
Zentrum fur Neurochirurgie der Uniklinik Koln
Köln, Germany, 50937
Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig
Leipzig, Germany, 04013
Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg
Mannheim, Germany, 68167
Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
Munchen, Germany, 81675
Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
Würzburg, Germany, 97080
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
New Kowloon, Hong Kong
Israel
Rabin Medical Center
Petaẖ Tiqwa, Petah-Tikva, Israel, 4941492
Rambam Health Care Center
Haifa, Israel, 3109606
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120
Sheba Medical Center
Ramat Gan, Israel
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Singapore
National Neuroscience Institute
Singapore, Singapore, 308433
Sponsors and Collaborators
Edge Therapeutics Inc
Investigators
Study Chair: R. Loch Macdonald, MD, PhD Edge Therapeutics Inc

Responsible Party: Edge Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02790632     History of Changes
Other Study ID Numbers: EG-01-1962-03
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Edge Therapeutics Inc:
Aneurysm, Ruptured
Nimodipine
Subarachnoid Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents