A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke

October 10, 2012 updated by: Ono Pharma USA Inc
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1320

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Modified Rankin Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Investigators

  • Study Director: Bryan Due, Ph.D., Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

October 2, 2002

First Submitted That Met QC Criteria

October 3, 2002

First Posted (ESTIMATE)

October 4, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2506/INT0104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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