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A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
This study has been terminated.
First Received: October 2, 2002   Last Updated: May 5, 2006   History of Changes
Sponsor: Ono Pharma
Information provided by: Ono Pharma
ClinicalTrials.gov Identifier: NCT00046761
  Purpose

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 Intervention Phase
Cerebrovascular Accident
 Drug: ONO-2506
 Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Arundic acid
U.S. FDA Resources

Further study details as provided by Ono Pharma:

Primary Outcome Measures:
  • Modified Rankin Scale

Estimated Enrollment: 1320
Study Start Date: November 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046761

  Hide Study Locations
Locations
United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95124
Alta Bates Hospital/ Summit Medical Center
Berkeley, California, United States, 94705
UCLA Medical Center
Los Angeles, California, United States, 90024
Stanford Stroke Center
Palo Alto, California, United States, 94304
Grossmont Hospital
La Mesa, California, United States, 91942
Mercy Medical Center
Redding, California, United States, 96001
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
UC Davis Medical Center
Sacramento, California, United States, 95817
Redding Medical Center
Redding, California, United States, 96001
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
The Stroke Center at Hartford Hospital
Hartford, Connecticut, United States, 06106
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
Bayfront Medical Center
St. Petersburg, Florida, United States, 33701
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Fawcett Memorial Hospital
Port Charlotte, Florida, United States, 33952
Munroe Regional Medical Center
Ocala, Florida, United States, 34478
BonSecours - St. Joseph's Hospital
Port Charlotte, Florida, United States, 33952
Memorial Hospital of Tampa
Tampa, Florida, United States, 33608
Ocala Regional Medical Center
Ocala, Florida, United States, 34471
Tampa General Hospital
Tampa, Florida, United States, 33606
Alachua General Hospital
Gainsville, Florida, United States, 32605
St. Joseph Hospital
Tampa, Florida, United States, 33606
Morton Plant Hospital
Clearwater, Florida, United States, 33756
North Broward Medical Center
Ft. Lauderdale, Florida, United States, 33308
Charlotte Regional Medical Center
Port Charlotte, Florida, United States, 33952
Aventura Hospital and Medical Center
Hollywood, Florida, United States, 33021
Palms of Pasadina Hospital
St. Petersburg, Florida, United States, 33707
Baptist Hospital of Miami
Miami, Florida, United States, 33156
Neurology Associates, PA
Maitland, Florida, United States, 32751
United States, Georgia
DeKalb Medical Center
Decatur, Georgia, United States, 30033
St. Francis Hospital
Columbus, Georgia, United States, 31901
Gwinnett Medical Center
Decatur, Georgia, United States, 30033
Joan Glancy Memorial Hospital
Decatur, Georgia, United States, 30034
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
Alexian Brothers Hospital
Elk Grove Village, Illinois, United States, 60007
Memorial Medical Center
Springfield, Illinois, United States, 62781
Advocate Christ Hospital & Medical Center
Oak Lawn, Illinois, United States, 60453
St. John's Hospital
Springfield, Illinois, United States, 62702
OSF St. Joseph Medical Center
Bloomington, Illinois, United States, 61704
Central DuPage Hospital
Warrenville, Illinois, United States, 60555
BroMenn Regional Medical Center
Bloomington, Illinois, United States, 61704
MacNeal Hospital
Berwyn, Illinois, United States, 60402
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46540
Parkview Hospital
Fort Wayne, Indiana, United States, 46805
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States, 46804
United States, Iowa
Mercy Hospital Medical Center
Des Moines, Iowa, United States, 50314
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Chandler Medical Center /Univ of Kentucky
Lexington, Kentucky, United States, 40536
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Lexington Clinic
Lexington, Kentucky, United States, 40504
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71130
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
Detroit Receiving Hospital/ Wayne State Univ
Detroit, Michigan, United States, 48201
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
St. Cloud Hospital
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. John's Clinic - Smith-Glynn-Callaway
Springfield, Missouri, United States, 65804
United States, Montana
Benefits Healthcare/ Advanced Neurology Specialists
Great Falls, Montana, United States, 59405
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Washoe Medical Center
Reno, Nevada, United States, 89502
United States, New Jersey
Muhlenberg Hospital
Plainfield, New Jersey, United States, 07061
JFK Medical Center
Edison, New Jersey, United States, 08818
Overlook Hospital
Summit, New Jersey, United States, 07091
Robert Wood Johnson Hospital
New Brunswick, New Jersey, United States, 08901
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Valley Hospital
Ridgewood, New Jersey, United States, 08629
Virtua Memorial Hospital
Medford, New Jersey, United States, 08055
Community Medical Center
Toms River, New Jersey, United States, 08755
Cooper Hospital /University Medical Center
Camden, New Jersey, United States, 08103
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New York
Ellis Hospital Stroke Center B421
Schenectady, New York, United States, 12308
Buffalo General Hospital
Buffalo, New York, United States, 14203
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Mt. Sinai Hospital
New York, New York, United States, 10029
North Shore University Hospital
Manhasset, New York, United States, 11030
Wilson Memorial Regional Medical Center
Johnson City, New York, United States, 13790
SUNY Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Strong Memorial Hospital
Rochester, New York, United States, 14642
Rochester General Hospital
Rochester, New York, United States, 14621
Mount Vernon Hospital
Mount Vernon, New York, United States, 10550
Winthrop University Hospital
Mineola, New York, United States, 11501
St. Peter's Hospital
Albany, New York, United States, 12208
Millard Fillmore Hospital
Buffalo, New York, United States, 14209
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27599
Rowan Regional Medical Center
Salisbury, North Carolina, United States, 28144
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Medical College of Ohio Hospital
Toledo, Ohio, United States, 43614
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
St. Elizabeth's Health Center
Youngstown, Ohio, United States, 44501
Kettering Medical Center -Wallace Kettering Neuroscience Inst.
Kettering, Ohio, United States, 45429
United States, Oregon
Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Oregon Health and Science University - Oregon Stroke Center
Portland, Oregon, United States, 97201
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence St. Vincent's Hospital
Portland, Oregon, United States, 97225
United States, Pennsylvania
Crozer Chester Medical Center
Upland, Pennsylvania, United States, 19013
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States, 15601
York Hospital
York, Pennsylvania, United States, 17402
University of Pittsburg Medical Center
Pittsburg, Pennsylvania, United States, 15213
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Greenville Hospital
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Erlanger Hospital
Chattanooga, Tennessee, United States, 37403
Regional Medical Center at Memphis
Memphis, Tennessee, United States, 38103
United States, Texas
Methodist Hospital /Baylor College of Medicine
Houston, Texas, United States, 77030
University Hospital /Univ of Texas Health Science Center
San Antonio, Texas, United States, 78229
Baylor University Medical Center
Dallas, Texas, United States, 75214
University of Texas; Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
St. Mary's Hospital
Richmond, Virginia, United States, 23226
Virginia Commonwealth University /Medical College of VA
Richmond, Virginia, United States, 23219
Henrico Doctors Hospital
Richmond, Virginia, United States, 23226
Memorial Regional Medical Center
Richmond, Virginia, United States, 23226
The Innovative Clincal Research Center
Alexandria, Virginia, United States, 22304
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25301
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Theda Clark Medical Center
Neenah, Wisconsin, United States, 54956
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States, 53792
St. Joseph's Hospital/ Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Foothills Medical Center /University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Lethbridge Regional Hospital
Lethbridge, Alberta, Canada, T1O 1W5
University of Alberta Hospital /Mackenzie Center
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 4R2
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 1T2
Royal Inland Hospital
Kamloops, British Columbia, Canada, V2C 2T1
St Paul's Hospital
Vancouver, British Columbia, Canada, U6Z 2A5
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 4A2
York Central Hospital
Richmond Hill, Ontario, Canada, L4C 9M7
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
Complexe Hospitalier de La Sagamie
Chicoutimi, Quebec, Canada, G7H 5H6
Hospital Notre Dame du Chum
Montreal, Quebec, Canada, H2L 4M1
Hotel-Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Centre Hospitalier des Vallees de l'Outaouais
Gatineau, Quebec, Canada, J8Y 1W7
Hotel-Dieu de St-Jerome
Saint-Jerome, Quebec, Canada, J7Z5T3
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Ono Pharma
Investigators
Study Director: Bryan Due, Ph.D. Ono Pharma
  More Information

No publications provided

Study ID Numbers: 2506/INT0104
Study First Received: October 2, 2002
Last Updated: May 5, 2006
ClinicalTrials.gov Identifier: NCT00046761     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharma:
Acute Ischemic Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
 Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 27, 2009



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