A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
- Conditions
- Cerebrovascular Accident
- Registration Number
- NCT00046761
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in patients with acute ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1320
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Modified Rankin Scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (148)
BonSecours - St. Joseph's Hospital
🇺🇸Port Charlotte, Florida, United States
Palms of Pasadina Hospital
🇺🇸St. Petersburg, Florida, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Washoe Medical Center
🇺🇸Reno, Nevada, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Advocate Christ Hospital & Medical Center
🇺🇸Oak Lawn, Illinois, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
Benefits Healthcare/ Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
University of Texas; Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
The Stroke Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Virtua Memorial Hospital
🇺🇸Medford, New Jersey, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Muhlenberg Hospital
🇺🇸Plainfield, New Jersey, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Royal Inland Hospital
🇨🇦Kamloops, British Columbia, Canada
Complexe Hospitalier de La Sagamie
🇨🇦Chicoutimi, Quebec, Canada
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Methodist Hospital /Baylor College of Medicine
🇺🇸Houston, Texas, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
University Hospital /Univ of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health and Science University - Oregon Stroke Center
🇺🇸Portland, Oregon, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Lexington Clinic
🇺🇸Lexington, Kentucky, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburg Medical Center
🇺🇸Pittsburg, Pennsylvania, United States
Crozer Chester Medical Center
🇺🇸Upland, Pennsylvania, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Alexian Brothers Hospital
🇺🇸Elk Grove Village, Illinois, United States
Fawcett Memorial Hospital
🇺🇸Port Charlotte, Florida, United States
Mercy Medical Center
🇺🇸Redding, California, United States
Alachua General Hospital
🇺🇸Gainsville, Florida, United States
Stanford Stroke Center
🇺🇸Palo Alto, California, United States
Good Samaritan Hospital
🇺🇸San Jose, California, United States
Aventura Hospital and Medical Center
🇺🇸Hollywood, Florida, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Charlotte Regional Medical Center
🇺🇸Port Charlotte, Florida, United States
Bayfront Medical Center
🇺🇸St. Petersburg, Florida, United States
DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Gwinnett Medical Center
🇺🇸Decatur, Georgia, United States
St. Francis Hospital
🇺🇸Columbus, Georgia, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Bloomington, Illinois, United States
OSF St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Central DuPage Hospital
🇺🇸Warrenville, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Chandler Medical Center /Univ of Kentucky
🇺🇸Lexington, Kentucky, United States
St. Cloud Hospital
🇺🇸St. Cloud, Minnesota, United States
University of Massachusetts Medical Center
🇺🇸Worcester, Massachusetts, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Wilson Memorial Regional Medical Center
🇺🇸Johnson City, New York, United States
St. Peter's Hospital
🇺🇸Albany, New York, United States
Cooper Hospital /University Medical Center
🇺🇸Camden, New Jersey, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Ellis Hospital Stroke Center B421
🇺🇸Schenectady, New York, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Greenville Hospital
🇺🇸Greenville, South Carolina, United States
Rogue Valley Medical Center
🇺🇸Medford, Oregon, United States
Providence St. Vincent's Hospital
🇺🇸Portland, Oregon, United States
Westmoreland Regional Hospital
🇺🇸Greensburg, Pennsylvania, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Erlanger Hospital
🇺🇸Chattanooga, Tennessee, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Memorial Regional Medical Center
🇺🇸Richmond, Virginia, United States
University of Alberta Hospital /Mackenzie Center
🇨🇦Edmonton, Alberta, Canada
Foothills Medical Center /University of Calgary
🇨🇦Calgary, Alberta, Canada
Lethbridge Regional Hospital
🇨🇦Lethbridge, Alberta, Canada
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Hotel-Dieu de Levis
🇨🇦Levis, Quebec, Canada
Hospital Notre Dame du Chum
🇨🇦Montreal, Quebec, Canada
York Central Hospital
🇨🇦Richmond Hill, Ontario, Canada
SUNY Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Rowan Regional Medical Center
🇺🇸Salisbury, North Carolina, United States
Lutheran Hospital of Indiana
🇺🇸Fort Wayne, Indiana, United States
Millard Fillmore Hospital
🇺🇸Buffalo, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University /Medical College of VA
🇺🇸Richmond, Virginia, United States
The Innovative Clincal Research Center
🇺🇸Alexandria, Virginia, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Neurology Associates, PA
🇺🇸Maitland, Florida, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Grossmont Hospital
🇺🇸La Mesa, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Alta Bates Hospital/ Summit Medical Center
🇺🇸Berkeley, California, United States
Redding Medical Center
🇺🇸Redding, California, United States
North Broward Medical Center
🇺🇸Ft. Lauderdale, Florida, United States
Ocala Regional Medical Center
🇺🇸Ocala, Florida, United States
Joan Glancy Memorial Hospital
🇺🇸Decatur, Georgia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
MacNeal Hospital
🇺🇸Berwyn, Illinois, United States
Mercy Hospital Medical Center
🇺🇸Des Moines, Iowa, United States
Detroit Receiving Hospital/ Wayne State Univ
🇺🇸Detroit, Michigan, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
St. John's Clinic - Smith-Glynn-Callaway
🇺🇸Springfield, Missouri, United States
Robert Wood Johnson Hospital
🇺🇸New Brunswick, New Jersey, United States
Kettering Medical Center -Wallace Kettering Neuroscience Inst.
🇺🇸Kettering, Ohio, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
Medical College of Ohio Hospital
🇺🇸Toledo, Ohio, United States
Mount Vernon Hospital
🇺🇸Mount Vernon, New York, United States
St. Elizabeth's Health Center
🇺🇸Youngstown, Ohio, United States
St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Regional Medical Center at Memphis
🇺🇸Memphis, Tennessee, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Henrico Doctors Hospital
🇺🇸Richmond, Virginia, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Joseph's Hospital/ Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Theda Clark Medical Center
🇺🇸Neenah, Wisconsin, United States
Centre Hospitalier des Vallees de l'Outaouais
🇨🇦Gatineau, Quebec, Canada
University of Wisconsin Hospitals and Clinics
🇺🇸Madison, Wisconsin, United States
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Hotel-Dieu de St-Jerome
🇨🇦Saint-Jerome, Quebec, Canada
Tampa General Hospital
🇺🇸Tampa, Florida, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Yale - New Haven Hospital
🇺🇸New Haven, Connecticut, United States
St. Joseph Hospital
🇺🇸Tampa, Florida, United States
Memorial Hospital of Tampa
🇺🇸Tampa, Florida, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States