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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— NEWTON2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02790632
• Other study ID #: EG-01-1962-03
• Status: Terminated
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Edge Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 374
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Nepean Hospital	Kingswood	New South Wales
Austria	Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie	Innsbruck
Canada	University of Alberta Hospital/Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame	Montréal	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Czechia	Faculty Hospital Brno	Brno	South Moravian Region
Czechia	Faculty Hospital Hradec Kralove	Hradec Králové	Hradec Kralov
Czechia	Faculty Hospital Ostrava	Ostrava
Czechia	Military University Hospital Prague	Prague
Finland	Helsinki University Hospital	Helsinki
Finland	Tampere University Hospital	Tampere	Pirkanmaa
Germany	Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM)	Berlin
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	Zentrum fur Neurochirurgie der Uniklinik Koln	Köln
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	Munchen
Germany	Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg	Würzburg
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	New Kowloon
Israel	Rambam Health Care Center	Haifa
Israel	Hadassah Hebrew University Medical Center	Jerusalem
Israel	Rabin Medical Center	Peta? Tiqwa	Petah-Tikva
Israel	Sheba Medical Center	Ramat Gan
New Zealand	Auckland City Hospital	Auckland
Singapore	National Neuroscience Institute	Singapore
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	University of Maryland Medical Systems	Baltimore	Maryland
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	UNC Hospitals Neuroscience Intensive Care Unit	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston Air Force Base	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Pavilion	Durham	North Carolina
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	University of California, San Francisco-Fresno	Fresno	California
United States	UF Health Shands Florida	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baptist Medical Center/Lyerly Neurosurgery	Jacksonville	Florida
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Keck Hospital of USC	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Semmes Murphey Neurological Clinic	Memphis	Tennessee
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Yale New Haven Hospital (YNHH)	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Jefferson Hospital for Neuroscience	Philadelphia	Pennsylvania
United States	Dignity Health; St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	VCU Medical Center	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	UCSF	San Francisco	California
United States	University of Washington, Harborview Medical Center	Seattle	Washington
United States	Tallahassee Neurological Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Edge Therapeutics Inc

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czechia,  Finland,  Germany,  Hong Kong,  Israel,  New Zealand,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Incidence and severity of adverse events in EG-1962 treated subjects compared to subjects treated with standard of care oral nimodipine	90 Days
Other	Delayed Cerebral Infarction	Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30	30 Days
Primary	Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]	Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90	90 Days
Secondary	Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint]	Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment (MoCA) at Day 90	90 Days