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DMC review concluded study has a low probability of meeting its primary endpoint
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This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EG-1962 Group | Experimental |
|
|
| Enteral Nimodipine Group | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG-1962 (nimodipine microparticles) | Drug | Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Delayed Cerebral Infarction | Proportion of subjects with delayed cerebral infarction present on CT scan at Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Loch Macdonald, MD, PhD | Edge Therapeutics Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
| Dignity Health; St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32138631 | Derived | 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. | |
| 30014184 |
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| Enteral Nimodipine | Drug | Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD |
|
| 30 Days |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| University of California, San Francisco-Fresno | Fresno | California | 93701 | United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| Yale New Haven Hospital (YNHH) | New Haven | Connecticut | 06510 | United States |
| UF Health Shands Florida | Gainesville | Florida | 32610 | United States |
| Baptist Medical Center/Lyerly Neurosurgery | Jacksonville | Florida | 32207 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612-7232 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| UNC Hospitals Neuroscience Intensive Care Unit | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Pavilion | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Jefferson Hospital for Neuroscience | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston Air Force Base | South Carolina | 29425 | United States |
| Semmes Murphey Neurological Clinic | Memphis | Tennessee | 38120 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| VCU Medical Center | Richmond | Virginia | 23298 | United States |
| University of Washington, Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 02747 | Australia |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Medizinische Universitat Innsbruck/Tirol Universitatsklinik fur Neurologie | Innsbruck | 06020 | Austria |
| University of Alberta Hospital/Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z1M9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM), Hopital Notre Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Faculty Hospital Hradec Kralove | Hradec Králové | Hradec Kralov | 50005 | Czechia |
| Faculty Hospital Brno | Brno | South Moravian | 62500 | Czechia |
| Faculty Hospital Ostrava | Ostrava | 708 52 | Czechia |
| Military University Hospital Prague | Prague | 16902 | Czechia |
| Tampere University Hospital | Tampere | Pirkanmaa | 33521 | Finland |
| Helsinki University Hospital | Helsinki | 00260 | Finland |
| Neuro Intensive Care Unit 102i; Campus Charite Mitte (CCM) | Berlin | 10117 | Germany |
| Zentrum fur Neurochirurgie der Uniklinik Koln | Cologne | 50937 | Germany |
| Universitatsklinikum Erlangen, Neurologische Klinik, Koptkliniken | Erlangen | 91054 | Germany |
| Klinik für Neurochirurgie des Universitätsklinikum Essen | Essen | 45147 | Germany |
| Klinik für Neurochirurgie, Zentrum der Neurologie und Neurochirurgie, Goethe-Universitätsklinikum Frankfurt am Main | Frankfurt am Main | 60528 | Germany |
| Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Neurochirurgie, Neues Klinikum | Hamburg | 20246 | Germany |
| Neurochirurgische Klinik der Universität Heidelberg | Heidelberg | 69120 | Germany |
| Klinik und Poliklinik für Neurochirurgie des Universitatsklinikum Leipzig | Leipzig | 04013 | Germany |
| Neurochirurgische Klinik, Universitatsmedizin Mannheim, Universität Heidelberg | Mannheim | 68167 | Germany |
| Neurochirurgische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universitat Munchen | München | 81675 | Germany |
| Neutochirurgische Klinik und Poliklinik des Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital | New Kowloon | Hong Kong |
| Rabin Medical Center | Petah Tikva | Petah-Tikva | 4941492 | Israel |
| Rambam Health Care Center | Haifa | 3109606 | Israel |
| Hadassah Hebrew University Medical Center | Jerusalem | 91120 | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| National Neuroscience Institute | Singapore | 308433 | Singapore |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D017542 | Aneurysm, Ruptured |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000783 | Aneurysm |
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| ID | Term |
|---|---|
| C000716088 | EG-1962 |
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