A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Sponsor
Ono Pharma USA Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00046761
Collaborator
(none)
1,320
148
8.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Study Start Date
:
Nov 1, 2002
Actual Primary Completion Date
:
May 1, 2005
Outcome Measures
Primary Outcome Measures
- Modified Rankin Scale []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brookwood Medical Center | Birmingham | Alabama | United States | 35209 |
| 2 | University of Alabama | Birmingham | Alabama | United States | 35294 |
| 3 | Alta Bates Hospital/ Summit Medical Center | Berkeley | California | United States | 94705 |
| 4 | Grossmont Hospital | La Mesa | California | United States | 91942 |
| 5 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 6 | UCLA Medical Center | Los Angeles | California | United States | 90024 |
| 7 | Stanford Stroke Center | Palo Alto | California | United States | 94304 |
| 8 | Mercy Medical Center | Redding | California | United States | 96001 |
| 9 | Redding Medical Center | Redding | California | United States | 96001 |
| 10 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
| 11 | Good Samaritan Hospital | San Jose | California | United States | 95124 |
| 12 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
| 13 | The Stroke Center at Hartford Hospital | Hartford | Connecticut | United States | 06106 |
| 14 | Yale - New Haven Hospital | New Haven | Connecticut | United States | 06520 |
| 15 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 16 | North Broward Medical Center | Ft. Lauderdale | Florida | United States | 33308 |
| 17 | Alachua General Hospital | Gainsville | Florida | United States | 32605 |
| 18 | Aventura Hospital and Medical Center | Hollywood | Florida | United States | 33021 |
| 19 | Neurology Associates, PA | Maitland | Florida | United States | 32751 |
| 20 | Baptist Hospital of Miami | Miami | Florida | United States | 33156 |
| 21 | Ocala Regional Medical Center | Ocala | Florida | United States | 34471 |
| 22 | Munroe Regional Medical Center | Ocala | Florida | United States | 34478 |
| 23 | BonSecours - St. Joseph's Hospital | Port Charlotte | Florida | United States | 33952 |
| 24 | Charlotte Regional Medical Center | Port Charlotte | Florida | United States | 33952 |
| 25 | Fawcett Memorial Hospital | Port Charlotte | Florida | United States | 33952 |
| 26 | Bayfront Medical Center | St. Petersburg | Florida | United States | 33701 |
| 27 | Palms of Pasadina Hospital | St. Petersburg | Florida | United States | 33707 |
| 28 | St. Joseph Hospital | Tampa | Florida | United States | 33606 |
| 29 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 30 | Memorial Hospital of Tampa | Tampa | Florida | United States | 33608 |
| 31 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
| 32 | St. Francis Hospital | Columbus | Georgia | United States | 31901 |
| 33 | DeKalb Medical Center | Decatur | Georgia | United States | 30033 |
| 34 | Gwinnett Medical Center | Decatur | Georgia | United States | 30033 |
| 35 | Joan Glancy Memorial Hospital | Decatur | Georgia | United States | 30034 |
| 36 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 37 | MacNeal Hospital | Berwyn | Illinois | United States | 60402 |
| 38 | BroMenn Regional Medical Center | Bloomington | Illinois | United States | 61704 |
| 39 | OSF St. Joseph Medical Center | Bloomington | Illinois | United States | 61704 |
| 40 | Alexian Brothers Hospital | Elk Grove Village | Illinois | United States | 60007 |
| 41 | Advocate Christ Hospital & Medical Center | Oak Lawn | Illinois | United States | 60453 |
| 42 | St. John's Hospital | Springfield | Illinois | United States | 62702 |
| 43 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 44 | Central DuPage Hospital | Warrenville | Illinois | United States | 60555 |
| 45 | Elkhart General Hospital | Elkhart | Indiana | United States | 46540 |
| 46 | Lutheran Hospital of Indiana | Fort Wayne | Indiana | United States | 46804 |
| 47 | Parkview Hospital | Fort Wayne | Indiana | United States | 46805 |
| 48 | Mercy Hospital Medical Center | Des Moines | Iowa | United States | 50314 |
| 49 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 50 | Lexington Clinic | Lexington | Kentucky | United States | 40504 |
| 51 | Chandler Medical Center /Univ of Kentucky | Lexington | Kentucky | United States | 40536 |
| 52 | University of Louisville Hospital | Louisville | Kentucky | United States | 40202 |
| 53 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 54 | LSU Health Sciences Center | Shreveport | Louisiana | United States | 71130 |
| 55 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 56 | University of Massachusetts Medical Center | Worcester | Massachusetts | United States | 01655 |
| 57 | Detroit Receiving Hospital/ Wayne State Univ | Detroit | Michigan | United States | 48201 |
| 58 | Borgess Research Institute | Kalamazoo | Michigan | United States | 49048 |
| 59 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
| 60 | St. Cloud Hospital | St. Cloud | Minnesota | United States | 56303 |
| 61 | North Mississippi Medical Center | Tupelo | Mississippi | United States | 38801 |
| 62 | St. John's Clinic - Smith-Glynn-Callaway | Springfield | Missouri | United States | 65804 |
| 63 | Benefits Healthcare/ Advanced Neurology Specialists | Great Falls | Montana | United States | 59405 |
| 64 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 65 | Washoe Medical Center | Reno | Nevada | United States | 89502 |
| 66 | Cooper Hospital /University Medical Center | Camden | New Jersey | United States | 08103 |
| 67 | JFK Medical Center | Edison | New Jersey | United States | 08818 |
| 68 | Englewood Hospital and Medical Center | Englewood | New Jersey | United States | 07631 |
| 69 | Virtua Memorial Hospital | Medford | New Jersey | United States | 08055 |
| 70 | Robert Wood Johnson Hospital | New Brunswick | New Jersey | United States | 08901 |
| 71 | Muhlenberg Hospital | Plainfield | New Jersey | United States | 07061 |
| 72 | Valley Hospital | Ridgewood | New Jersey | United States | 08629 |
| 73 | Overlook Hospital | Summit | New Jersey | United States | 07091 |
| 74 | Community Medical Center | Toms River | New Jersey | United States | 08755 |
| 75 | St. Francis Medical Center | Trenton | New Jersey | United States | 08629 |
| 76 | St. Peter's Hospital | Albany | New York | United States | 12208 |
| 77 | Buffalo General Hospital | Buffalo | New York | United States | 14203 |
| 78 | Millard Fillmore Hospital | Buffalo | New York | United States | 14209 |
| 79 | Wilson Memorial Regional Medical Center | Johnson City | New York | United States | 13790 |
| 80 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 81 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 82 | Mount Vernon Hospital | Mount Vernon | New York | United States | 10550 |
| 83 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 84 | Mt. Sinai Hospital | New York | New York | United States | 10029 |
| 85 | Rochester General Hospital | Rochester | New York | United States | 14621 |
| 86 | Strong Memorial Hospital | Rochester | New York | United States | 14642 |
| 87 | Ellis Hospital Stroke Center B421 | Schenectady | New York | United States | 12308 |
| 88 | SUNY Stony Brook University Hospital | Stony Brook | New York | United States | 11794 |
| 89 | University of North Carolina Hospital | Chapel Hill | North Carolina | United States | 27599 |
| 90 | Rowan Regional Medical Center | Salisbury | North Carolina | United States | 28144 |
| 91 | Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 92 | Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 93 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 94 | Metrohealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 95 | Kettering Medical Center -Wallace Kettering Neuroscience Inst. | Kettering | Ohio | United States | 45429 |
| 96 | Medical College of Ohio Hospital | Toledo | Ohio | United States | 43614 |
| 97 | St. Elizabeth's Health Center | Youngstown | Ohio | United States | 44501 |
| 98 | Rogue Valley Medical Center | Medford | Oregon | United States | 97504 |
| 99 | Oregon Health and Science University - Oregon Stroke Center | Portland | Oregon | United States | 97201 |
| 100 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 101 | Providence St. Vincent's Hospital | Portland | Oregon | United States | 97225 |
| 102 | Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18103 |
| 103 | Westmoreland Regional Hospital | Greensburg | Pennsylvania | United States | 15601 |
| 104 | University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
| 105 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 106 | University of Pittsburg Medical Center | Pittsburg | Pennsylvania | United States | 15213 |
| 107 | Crozer Chester Medical Center | Upland | Pennsylvania | United States | 19013 |
| 108 | York Hospital | York | Pennsylvania | United States | 17402 |
| 109 | Miriam Hospital | Providence | Rhode Island | United States | 02906 |
| 110 | Greenville Hospital | Greenville | South Carolina | United States | 29615 |
| 111 | Erlanger Hospital | Chattanooga | Tennessee | United States | 37403 |
| 112 | Regional Medical Center at Memphis | Memphis | Tennessee | United States | 38103 |
| 113 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 114 | Baylor University Medical Center | Dallas | Texas | United States | 75214 |
| 115 | University of Texas; Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390 |
| 116 | Methodist Hospital /Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 117 | The Methodist Hospital | Houston | Texas | United States | 77030 |
| 118 | University Hospital /Univ of Texas Health Science Center | San Antonio | Texas | United States | 78229 |
| 119 | University of Utah Medical Center | Salt Lake City | Utah | United States | 84132 |
| 120 | The Innovative Clincal Research Center | Alexandria | Virginia | United States | 22304 |
| 121 | Virginia Commonwealth University /Medical College of VA | Richmond | Virginia | United States | 23219 |
| 122 | Henrico Doctors Hospital | Richmond | Virginia | United States | 23226 |
| 123 | Memorial Regional Medical Center | Richmond | Virginia | United States | 23226 |
| 124 | St. Mary's Hospital | Richmond | Virginia | United States | 23226 |
| 125 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 126 | Charleston Area Medical Center | Charleston | West Virginia | United States | 25301 |
| 127 | University of Wisconsin Hospitals and Clinics | Madison | Wisconsin | United States | 53792 |
| 128 | St. Joseph's Hospital/ Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 129 | St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 130 | Theda Clark Medical Center | Neenah | Wisconsin | United States | 54956 |
| 131 | Foothills Medical Center /University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
| 132 | University of Alberta Hospital /Mackenzie Center | Edmonton | Alberta | Canada | T6G 2B7 |
| 133 | Lethbridge Regional Hospital | Lethbridge | Alberta | Canada | T1O 1W5 |
| 134 | Royal Inland Hospital | Kamloops | British Columbia | Canada | V2C 2T1 |
| 135 | Kelowna General Hospital | Kelowna | British Columbia | Canada | V1Y 1T2 |
| 136 | St Paul's Hospital | Vancouver | British Columbia | Canada | U6Z 2A5 |
| 137 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 138 | Royal Jubilee Hospital | Victoria | British Columbia | Canada | V8R 4R2 |
| 139 | Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
| 140 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 141 | Trillium Health Centre | Mississauga | Ontario | Canada | L5B 4A2 |
| 142 | York Central Hospital | Richmond Hill | Ontario | Canada | L4C 9M7 |
| 143 | Complexe Hospitalier de La Sagamie | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 144 | Centre Hospitalier des Vallees de l'Outaouais | Gatineau | Quebec | Canada | J8Y 1W7 |
| 145 | Hotel-Dieu de Levis | Levis | Quebec | Canada | G6V 3Z1 |
| 146 | Hospital Notre Dame du Chum | Montreal | Quebec | Canada | H2L 4M1 |
| 147 | Hotel-Dieu de St-Jerome | Saint-Jerome | Quebec | Canada | J7Z5T3 |
| 148 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
Sponsors and Collaborators
- Ono Pharma USA Inc
Investigators
- Study Director: Bryan Due, Ph.D., Ono Pharma USA Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ono Pharma USA Inc
ClinicalTrials.gov Identifier:
NCT00046761
Other Study ID Numbers:
- 2506/INT0104
First Posted:
Oct 4, 2002
Last Update Posted:
Oct 11, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Ono Pharma USA Inc
Additional relevant MeSH terms: