Clinical trial NCT02790632: Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: Aneurysm, Ruptured
Nimodipine
Subarachnoid Hemorrhage
Lead sponsor: Edge Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
timeFrame: 90 Days
Secondary outcomes:
measure: Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]
timeFrame: 90 Days
Other outcomes:
measure: Adverse Events
timeFrame: 90 Days
measure: Delayed Cerebral Infarction
timeFrame: 30 Days
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Phoenix
country: United States
facility: Dignity Health; St. Joseph's Hospital and Medical Center
state: Arizona
city: Fresno
country: United States
facility: University of California, San Francisco-Fresno
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital (YNHH)
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Shands Florida
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center/Lyerly Neurosurgery
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Systems
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals Neuroscience Intensive Care Unit
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Pavilion
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital for Neuroscience
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Charleston Air Force Base
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey Neurological Clinic
state: Tennessee
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington, Harborview Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie
city: Edmonton
country: Canada
facility: University of Alberta Hospital/Mackenzie Health Sciences Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Hradec Králové
country: Czechia
facility: Faculty Hospital Hradec Kralove
state: Hradec Kralov
city: Brno
country: Czechia
facility: Faculty Hospital Brno
state: South Moravian Region
city: Ostrava
country: Czechia
facility: Faculty Hospital Ostrava
city: Prague
country: Czechia
facility: Military University Hospital Prague
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Berlin
country: Germany
facility: Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken
city: Essen
country: Germany
facility: Klinik für Neurochirurgie des Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum
city: Heidelberg
country: Germany
facility: Neurochirurgische Klinik der Universität Heidelberg
city: Köln
country: Germany
facility: Zentrum fur Neurochirurgie der Uniklinik Koln
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig
city: Mannheim
country: Germany
facility: Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg
city: Munchen
country: Germany
facility: Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen
city: Würzburg
country: Germany
facility: Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: New Kowloon
country: Hong Kong
facility: Prince of Wales Hospital
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center
state: Petah-Tikva
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Singapore
country: Singapore
facility: National Neuroscience Institute
Study officials:
affiliation: Edge Therapeutics Inc
name: R. Loch Macdonald, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.