A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Cerebrovascular Accident
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Patient must have a clinical diagnosis of acute cortical ischemic stroke. Patient must be randomized into the study within six hours after the initial onset of stroke symptoms. Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes. Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke. Patient must have had a pre-stroke mRS scale score of 0 or 1. Other inclusion criteria as specified in the study protocol. Exclusion Criteria: Patient must not have a body weight of more than 125 kg. Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage. Patient must not have all three of the following findings: reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a) forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg). Patient must not have neurological signs and symptoms that are rapidly improving. Patient must not have a severe coexisting or terminal systemic disease. Patient must not be pregnant or lactating. Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites. Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL. Patient must not have congestive heart failure. Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block. Patient must not have other exclusion criteria as specified in the study protocol.
Sites / Locations
- Brookwood Medical Center
- University of Alabama
- Alta Bates Hospital/ Summit Medical Center
- Grossmont Hospital
- Loma Linda University Medical Center
- UCLA Medical Center
- Stanford Stroke Center
- Mercy Medical Center
- Redding Medical Center
- UC Davis Medical Center
- Good Samaritan Hospital
- Bridgeport Hospital
- The Stroke Center at Hartford Hospital
- Yale - New Haven Hospital
- Morton Plant Hospital
- North Broward Medical Center
- Alachua General Hospital
- Aventura Hospital and Medical Center
- Neurology Associates, PA
- Baptist Hospital of Miami
- Ocala Regional Medical Center
- Munroe Regional Medical Center
- BonSecours - St. Joseph's Hospital
- Charlotte Regional Medical Center
- Fawcett Memorial Hospital
- Bayfront Medical Center
- Palms of Pasadina Hospital
- St. Joseph Hospital
- Tampa General Hospital
- Memorial Hospital of Tampa
- Cleveland Clinic Florida
- St. Francis Hospital
- DeKalb Medical Center
- Gwinnett Medical Center
- Joan Glancy Memorial Hospital
- Queen's Medical Center
- MacNeal Hospital
- BroMenn Regional Medical Center
- OSF St. Joseph Medical Center
- Alexian Brothers Hospital
- Advocate Christ Hospital & Medical Center
- St. John's Hospital
- Memorial Medical Center
- Central DuPage Hospital
- Elkhart General Hospital
- Lutheran Hospital of Indiana
- Parkview Hospital
- Mercy Hospital Medical Center
- University of Kansas Medical Center
- Lexington Clinic
- Chandler Medical Center /Univ of Kentucky
- University of Louisville Hospital
- Ochsner Clinic Foundation
- LSU Health Sciences Center
- Sinai Hospital of Baltimore
- University of Massachusetts Medical Center
- Detroit Receiving Hospital/ Wayne State Univ
- Borgess Research Institute
- William Beaumont Hospital
- St. Cloud Hospital
- North Mississippi Medical Center
- St. John's Clinic - Smith-Glynn-Callaway
- Benefits Healthcare/ Advanced Neurology Specialists
- Creighton University Medical Center
- Washoe Medical Center
- Cooper Hospital /University Medical Center
- JFK Medical Center
- Englewood Hospital and Medical Center
- Virtua Memorial Hospital
- Robert Wood Johnson Hospital
- Muhlenberg Hospital
- Valley Hospital
- Overlook Hospital
- Community Medical Center
- St. Francis Medical Center
- St. Peter's Hospital
- Buffalo General Hospital
- Millard Fillmore Hospital
- Wilson Memorial Regional Medical Center
- North Shore University Hospital
- Winthrop University Hospital
- Mount Vernon Hospital
- Long Island Jewish Medical Center
- Mt. Sinai Hospital
- Rochester General Hospital
- Strong Memorial Hospital
- Ellis Hospital Stroke Center B421
- SUNY Stony Brook University Hospital
- University of North Carolina Hospital
- Rowan Regional Medical Center
- Forsyth Medical Center
- Akron General Medical Center
- University Hospitals of Cleveland
- Metrohealth Medical Center
- Kettering Medical Center -Wallace Kettering Neuroscience Inst.
- Medical College of Ohio Hospital
- St. Elizabeth's Health Center
- Rogue Valley Medical Center
- Oregon Health and Science University - Oregon Stroke Center
- Providence Portland Medical Center
- Providence St. Vincent's Hospital
- Lehigh Valley Hospital
- Westmoreland Regional Hospital
- University of Pennsylvania Medical Center
- Thomas Jefferson University Hospital
- University of Pittsburg Medical Center
- Crozer Chester Medical Center
- York Hospital
- Miriam Hospital
- Greenville Hospital
- Erlanger Hospital
- Regional Medical Center at Memphis
- Vanderbilt University Medical Center
- Baylor University Medical Center
- University of Texas; Southwestern Medical Center at Dallas
- Methodist Hospital /Baylor College of Medicine
- The Methodist Hospital
- University Hospital /Univ of Texas Health Science Center
- University of Utah Medical Center
- The Innovative Clincal Research Center
- Virginia Commonwealth University /Medical College of VA
- Henrico Doctors Hospital
- Memorial Regional Medical Center
- St. Mary's Hospital
- Harborview Medical Center
- Charleston Area Medical Center
- University of Wisconsin Hospitals and Clinics
- St. Joseph's Hospital/ Marshfield Clinic
- St. Luke's Medical Center
- Theda Clark Medical Center
- Foothills Medical Center /University of Calgary
- University of Alberta Hospital /Mackenzie Center
- Lethbridge Regional Hospital
- Royal Inland Hospital
- Kelowna General Hospital
- St Paul's Hospital
- Vancouver General Hospital
- Royal Jubilee Hospital
- Kingston General Hospital
- London Health Sciences Centre
- Trillium Health Centre
- York Central Hospital
- Complexe Hospitalier de La Sagamie
- Centre Hospitalier des Vallees de l'Outaouais
- Hotel-Dieu de Levis
- Hospital Notre Dame du Chum
- Hotel-Dieu de St-Jerome
- Royal University Hospital