A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
1 other identifier
interventional
1,320
2 countries
148
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2002
CompletedFirst Posted
Study publicly available on registry
October 4, 2002
CompletedStudy Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedOctober 11, 2012
October 1, 2012
2.5 years
October 2, 2002
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
Brookwood Medical Center
Birmingham, Alabama, 35209, United States
University of Alabama
Birmingham, Alabama, 35294, United States
Alta Bates Hospital/ Summit Medical Center
Berkeley, California, 94705, United States
Grossmont Hospital
La Mesa, California, 91942, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
UCLA Medical Center
Los Angeles, California, 90024, United States
Stanford Stroke Center
Palo Alto, California, 94304, United States
Mercy Medical Center
Redding, California, 96001, United States
Redding Medical Center
Redding, California, 96001, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
The Stroke Center at Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale - New Haven Hospital
New Haven, Connecticut, 06520, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
North Broward Medical Center
Fort Lauderdale, Florida, 33308, United States
Alachua General Hospital
Gainsville, Florida, 32605, United States
Aventura Hospital and Medical Center
Hollywood, Florida, 33021, United States
Neurology Associates, PA
Maitland, Florida, 32751, United States
Baptist Hospital of Miami
Miami, Florida, 33156, United States
Ocala Regional Medical Center
Ocala, Florida, 34471, United States
Munroe Regional Medical Center
Ocala, Florida, 34478, United States
BonSecours - St. Joseph's Hospital
Port Charlotte, Florida, 33952, United States
Charlotte Regional Medical Center
Port Charlotte, Florida, 33952, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
Bayfront Medical Center
St. Petersburg, Florida, 33701, United States
Palms of Pasadina Hospital
St. Petersburg, Florida, 33707, United States
St. Joseph Hospital
Tampa, Florida, 33606, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Memorial Hospital of Tampa
Tampa, Florida, 33608, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
St. Francis Hospital
Columbus, Georgia, 31901, United States
DeKalb Medical Center
Decatur, Georgia, 30033, United States
Gwinnett Medical Center
Decatur, Georgia, 30033, United States
Joan Glancy Memorial Hospital
Decatur, Georgia, 30034, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
MacNeal Hospital
Berwyn, Illinois, 60402, United States
BroMenn Regional Medical Center
Bloomington, Illinois, 61704, United States
OSF St. Joseph Medical Center
Bloomington, Illinois, 61704, United States
Alexian Brothers Hospital
Elk Grove Village, Illinois, 60007, United States
Advocate Christ Hospital & Medical Center
Oak Lawn, Illinois, 60453, United States
St. John's Hospital
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Central DuPage Hospital
Warrenville, Illinois, 60555, United States
Elkhart General Hospital
Elkhart, Indiana, 46540, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804, United States
Parkview Hospital
Fort Wayne, Indiana, 46805, United States
Mercy Hospital Medical Center
Des Moines, Iowa, 50314, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Lexington Clinic
Lexington, Kentucky, 40504, United States
Chandler Medical Center /Univ of Kentucky
Lexington, Kentucky, 40536, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71130, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
Detroit Receiving Hospital/ Wayne State Univ
Detroit, Michigan, 48201, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
St. John's Clinic - Smith-Glynn-Callaway
Springfield, Missouri, 65804, United States
Benefits Healthcare/ Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Washoe Medical Center
Reno, Nevada, 89502, United States
Cooper Hospital /University Medical Center
Camden, New Jersey, 08103, United States
JFK Medical Center
Edison, New Jersey, 08818, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Virtua Memorial Hospital
Medford, New Jersey, 08055, United States
Robert Wood Johnson Hospital
New Brunswick, New Jersey, 08901, United States
Muhlenberg Hospital
Plainfield, New Jersey, 07061, United States
Valley Hospital
Ridgewood, New Jersey, 08629, United States
Overlook Hospital
Summit, New Jersey, 07091, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
St. Francis Medical Center
Trenton, New Jersey, 08629, United States
St. Peter's Hospital
Albany, New York, 12208, United States
Buffalo General Hospital
Buffalo, New York, 14203, United States
Millard Fillmore Hospital
Buffalo, New York, 14209, United States
Wilson Memorial Regional Medical Center
Johnson City, New York, 13790, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Vernon Hospital
Mount Vernon, New York, 10550, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Ellis Hospital Stroke Center B421
Schenectady, New York, 12308, United States
SUNY Stony Brook University Hospital
Stony Brook, New York, 11794, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Rowan Regional Medical Center
Salisbury, North Carolina, 28144, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Metrohealth Medical Center
Cleveland, Ohio, 44109, United States
Kettering Medical Center -Wallace Kettering Neuroscience Inst.
Kettering, Ohio, 45429, United States
Medical College of Ohio Hospital
Toledo, Ohio, 43614, United States
St. Elizabeth's Health Center
Youngstown, Ohio, 44501, United States
Rogue Valley Medical Center
Medford, Oregon, 97504, United States
Oregon Health and Science University - Oregon Stroke Center
Portland, Oregon, 97201, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence St. Vincent's Hospital
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Crozer Chester Medical Center
Upland, Pennsylvania, 19013, United States
York Hospital
York, Pennsylvania, 17402, United States
Miriam Hospital
Providence, Rhode Island, 02906, United States
Greenville Hospital
Greenville, South Carolina, 29615, United States
Erlanger Hospital
Chattanooga, Tennessee, 37403, United States
Regional Medical Center at Memphis
Memphis, Tennessee, 38103, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75214, United States
University of Texas; Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Methodist Hospital /Baylor College of Medicine
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University Hospital /Univ of Texas Health Science Center
San Antonio, Texas, 78229, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
The Innovative Clincal Research Center
Alexandria, Virginia, 22304, United States
Virginia Commonwealth University /Medical College of VA
Richmond, Virginia, 23219, United States
Henrico Doctors Hospital
Richmond, Virginia, 23226, United States
Memorial Regional Medical Center
Richmond, Virginia, 23226, United States
St. Mary's Hospital
Richmond, Virginia, 23226, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Charleston Area Medical Center
Charleston, West Virginia, 25301, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792, United States
St. Joseph's Hospital/ Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Theda Clark Medical Center
Neenah, Wisconsin, 54956, United States
Foothills Medical Center /University of Calgary
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital /Mackenzie Center
Edmonton, Alberta, T6G 2B7, Canada
Lethbridge Regional Hospital
Lethbridge, Alberta, T1O 1W5, Canada
Royal Inland Hospital
Kamloops, British Columbia, V2C 2T1, Canada
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2, Canada
St Paul's Hospital
Vancouver, British Columbia, U6Z 2A5, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Royal Jubilee Hospital
Victoria, British Columbia, V8R 4R2, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 4A2, Canada
York Central Hospital
Richmond Hill, Ontario, L4C 9M7, Canada
Complexe Hospitalier de La Sagamie
Chicoutimi, Quebec, G7H 5H6, Canada
Centre Hospitalier des Vallees de l'Outaouais
Gatineau, Quebec, J8Y 1W7, Canada
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
Hospital Notre Dame du Chum
Montreal, Quebec, H2L 4M1, Canada
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec, J7Z5T3, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bryan Due, Ph.D.
Ono Pharma USA Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2002
First Posted
October 4, 2002
Study Start
November 1, 2002
Primary Completion
May 1, 2005
Last Updated
October 11, 2012
Record last verified: 2012-10