Cerebrovascular Accident Clinical Trial
Official title:
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
| Verified date | October 2012 |
| Source | Ono Pharmaceutical Co. Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 1320 |
| Est. completion date | |
| Est. primary completion date | May 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: 1. reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a) 2. forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and 3. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Medical Center /University of Calgary | Calgary | Alberta |
| Canada | Complexe Hospitalier de La Sagamie | Chicoutimi | Quebec |
| Canada | University of Alberta Hospital /Mackenzie Center | Edmonton | Alberta |
| Canada | Centre Hospitalier des Vallees de l'Outaouais | Gatineau | Quebec |
| Canada | Royal Inland Hospital | Kamloops | British Columbia |
| Canada | Kelowna General Hospital | Kelowna | British Columbia |
| Canada | Kingston General Hospital | Kingston | Ontario |
| Canada | Lethbridge Regional Hospital | Lethbridge | Alberta |
| Canada | Hotel-Dieu de Levis | Levis | Quebec |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Trillium Health Centre | Mississauga | Ontario |
| Canada | Hospital Notre Dame du Chum | Montreal | Quebec |
| Canada | York Central Hospital | Richmond Hill | Ontario |
| Canada | Hotel-Dieu de St-Jerome | Saint-Jerome | Quebec |
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | St Paul's Hospital | Vancouver | British Columbia |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Canada | Royal Jubilee Hospital | Victoria | British Columbia |
| United States | Akron General Medical Center | Akron | Ohio |
| United States | St. Peter's Hospital | Albany | New York |
| United States | The Innovative Clincal Research Center | Alexandria | Virginia |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
| United States | Alta Bates Hospital/ Summit Medical Center | Berkeley | California |
| United States | MacNeal Hospital | Berwyn | Illinois |
| United States | Brookwood Medical Center | Birmingham | Alabama |
| United States | University of Alabama | Birmingham | Alabama |
| United States | BroMenn Regional Medical Center | Bloomington | Illinois |
| United States | OSF St. Joseph Medical Center | Bloomington | Illinois |
| United States | Bridgeport Hospital | Bridgeport | Connecticut |
| United States | Buffalo General Hospital | Buffalo | New York |
| United States | Millard Fillmore Hospital | Buffalo | New York |
| United States | Cooper Hospital /University Medical Center | Camden | New Jersey |
| United States | University of North Carolina Hospital | Chapel Hill | North Carolina |
| United States | Charleston Area Medical Center | Charleston | West Virginia |
| United States | Erlanger Hospital | Chattanooga | Tennessee |
| United States | Morton Plant Hospital | Clearwater | Florida |
| United States | Metrohealth Medical Center | Cleveland | Ohio |
| United States | University Hospitals of Cleveland | Cleveland | Ohio |
| United States | St. Francis Hospital | Columbus | Georgia |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | University of Texas; Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | DeKalb Medical Center | Decatur | Georgia |
| United States | Gwinnett Medical Center | Decatur | Georgia |
| United States | Joan Glancy Memorial Hospital | Decatur | Georgia |
| 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 | Alexian Brothers Hospital | Elk Grove Village | Illinois |
| United States | Elkhart General Hospital | Elkhart | Indiana |
| United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
| United States | Lutheran Hospital of Indiana | Fort Wayne | Indiana |
| United States | Parkview Hospital | Fort Wayne | Indiana |
| United States | North Broward Medical Center | Ft. Lauderdale | Florida |
| United States | Alachua General Hospital | Gainsville | Florida |
| United States | Benefits Healthcare/ Advanced Neurology Specialists | Great Falls | Montana |
| United States | Westmoreland Regional Hospital | Greensburg | Pennsylvania |
| United States | Greenville Hospital | Greenville | South Carolina |
| United States | The Stroke Center at Hartford Hospital | Hartford | Connecticut |
| United States | Aventura Hospital and Medical Center | Hollywood | Florida |
| United States | Queen's Medical Center | Honolulu | Hawaii |
| United States | Methodist Hospital /Baylor College of Medicine | Houston | Texas |
| United States | The Methodist Hospital | Houston | Texas |
| United States | Wilson Memorial Regional Medical Center | Johnson City | New York |
| United States | Borgess Research Institute | Kalamazoo | Michigan |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Kettering Medical Center -Wallace Kettering Neuroscience Inst. | Kettering | Ohio |
| United States | Grossmont Hospital | La Mesa | California |
| United States | Chandler Medical Center /Univ of Kentucky | Lexington | Kentucky |
| United States | Lexington Clinic | Lexington | Kentucky |
| United States | Loma Linda University Medical Center | Loma Linda | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | University of Louisville Hospital | Louisville | Kentucky |
| United States | University of Wisconsin Hospitals and Clinics | Madison | Wisconsin |
| United States | Neurology Associates, PA | Maitland | Florida |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | St. Joseph's Hospital/ Marshfield Clinic | Marshfield | Wisconsin |
| United States | Rogue Valley Medical Center | Medford | Oregon |
| United States | Virtua Memorial Hospital | Medford | New Jersey |
| United States | Regional Medical Center at Memphis | Memphis | Tennessee |
| United States | Baptist Hospital of Miami | Miami | Florida |
| United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Mount Vernon Hospital | Mount Vernon | New York |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Theda Clark Medical Center | Neenah | Wisconsin |
| United States | Robert Wood Johnson Hospital | New Brunswick | New Jersey |
| United States | Yale - New Haven Hospital | New Haven | Connecticut |
| United States | Long Island Jewish Medical Center | New Hyde Park | New York |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Mt. Sinai Hospital | New York | New York |
| United States | Advocate Christ Hospital & Medical Center | Oak Lawn | Illinois |
| United States | Munroe Regional Medical Center | Ocala | Florida |
| United States | Ocala Regional Medical Center | Ocala | Florida |
| United States | Creighton University Medical Center | Omaha | Nebraska |
| United States | Stanford Stroke Center | Palo Alto | California |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
| United States | University of Pittsburg Medical Center | Pittsburg | Pennsylvania |
| United States | Muhlenberg Hospital | Plainfield | New Jersey |
| United States | BonSecours - St. Joseph's Hospital | Port Charlotte | Florida |
| United States | Charlotte Regional Medical Center | Port Charlotte | Florida |
| United States | Fawcett Memorial Hospital | Port Charlotte | Florida |
| United States | Oregon Health and Science University - Oregon Stroke Center | Portland | Oregon |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Providence St. Vincent's Hospital | Portland | Oregon |
| United States | Miriam Hospital | Providence | Rhode Island |
| United States | Mercy Medical Center | Redding | California |
| United States | Redding Medical Center | Redding | California |
| United States | Washoe Medical Center | Reno | Nevada |
| United States | Henrico Doctors Hospital | Richmond | Virginia |
| United States | Memorial Regional Medical Center | Richmond | Virginia |
| United States | St. Mary's Hospital | Richmond | Virginia |
| United States | Virginia Commonwealth University /Medical College of VA | Richmond | Virginia |
| United States | Valley Hospital | Ridgewood | New Jersey |
| United States | Rochester General Hospital | Rochester | New York |
| United States | Strong Memorial Hospital | Rochester | New York |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | Rowan Regional Medical Center | Salisbury | North Carolina |
| United States | University of Utah Medical Center | Salt Lake City | Utah |
| United States | University Hospital /Univ of Texas Health Science Center | San Antonio | Texas |
| United States | Good Samaritan Hospital | San Jose | California |
| United States | Ellis Hospital Stroke Center B421 | Schenectady | New York |
| United States | Harborview Medical Center | Seattle | Washington |
| United States | LSU Health Sciences Center | Shreveport | Louisiana |
| United States | Memorial Medical Center | Springfield | Illinois |
| United States | St. John's Clinic - Smith-Glynn-Callaway | Springfield | Missouri |
| United States | St. John's Hospital | Springfield | Illinois |
| United States | St. Cloud Hospital | St. Cloud | Minnesota |
| United States | Bayfront Medical Center | St. Petersburg | Florida |
| United States | Palms of Pasadina Hospital | St. Petersburg | Florida |
| United States | SUNY Stony Brook University Hospital | Stony Brook | New York |
| United States | Overlook Hospital | Summit | New Jersey |
| United States | Memorial Hospital of Tampa | Tampa | Florida |
| United States | St. Joseph Hospital | Tampa | Florida |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Medical College of Ohio Hospital | Toledo | Ohio |
| United States | Community Medical Center | Toms River | New Jersey |
| United States | St. Francis Medical Center | Trenton | New Jersey |
| United States | North Mississippi Medical Center | Tupelo | Mississippi |
| United States | Crozer Chester Medical Center | Upland | Pennsylvania |
| United States | Central DuPage Hospital | Warrenville | Illinois |
| United States | Cleveland Clinic Florida | Weston | Florida |
| United States | Forsyth Medical Center | Winston-Salem | North Carolina |
| United States | University of Massachusetts Medical Center | Worcester | Massachusetts |
| United States | York Hospital | York | Pennsylvania |
| United States | St. Elizabeth's Health Center | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharma USA Inc |
United States, Canada,
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