A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke
1 other identifier
interventional
N/A
6 countries
89
Brief Summary
This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2000
89 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
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 16, 2002
CompletedFirst Posted
Study publicly available on registry
August 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedApril 3, 2006
March 1, 2006
August 16, 2002
March 31, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
- Patients who have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
- Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
- Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
- Patients who are at least 18 years of age.
- Other criteria as specified in the study protocol
You may not qualify if:
- Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
- Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
- Patients who have brain hemorrhage.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
- Patients who have renal (kidney) disease or insufficiency.
- Patients who have active epilepsy or convulsions during the current stroke episode.
- Patients who are IV drug users or are inebriated.
- Patients who have a history of drug-related anaphylaxis.
- Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
- Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
- Patients who have a known vitamin hypersensitivity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (89)
University of South Alabama Stroke Center
Mobile, Alabama, United States
Phoenix Neurology Associates (Good Samaritan Hospital)
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Providence St. Joseph's Medical Center
Burbank, California, United States
Grossmont Hospital
La Mesa, California, United States
UCLA Emergency Medical Center
Los Angeles, California, United States
Good Samaritan Hospital
San Jose, California, United States
Santa Monica UCLA Medical Center
Santa Monica, California, United States
John Muir Medical Center
Walnut Creek, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
University of Miami (Jackson Memorial Hospital)
Miami, Florida, United States
Florida Neurovascular Institute
Tampa, Florida, United States
DNA Research (Dekalb Medical Center)
Decatur, Georgia, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Parkview Hospital
Fort Wayne, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Louisville Neuroscience Research Center
Louisville, Kentucky, United States
Cullicchia Neurology Clinic, LLP
Marrero, Louisiana, United States
Johns Hopkins Medical Institute
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New England Medical Center
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Field Neurosciences Institute (St. Mary's Hospital)
Saginaw, Michigan, United States
Advanced Neurology Specialists (Benefis Healthcare Hospital)
Great Falls, Montana, United States
St. Patrick's Hospital & Health Sciences Center
Missoula, Montana, United States
Washoe Comprehensive Stroke Center
Reno, Nevada, United States
JFK Medical Center
Edison, New Jersey, United States
Neurology Group of Bergen County (Valley Hospital)
Ridgewood, New Jersey, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
VA Medical Center
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Buffalo General Hospital
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
St. Luke's Hospital
New York, New York, United States
Ellis Hospital
Schenectady, New York, United States
Stony Brook Hospital
Stony Brook, New York, United States
All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
Winston-Salem, North Carolina, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Medical College of Ohio
Toledo, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center Stroke Institute
Pittsburgh, Pennsylvania, United States
Chattanooga Neurology Associates (Erlanger Hospital)
Chattanooga, Tennessee, United States
Chattanooga Neurology Associates (Memorial Hospital)
Chattanooga, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas (Houston Medical Center)
Houston, Texas, United States
Neurology Associates, Inc. (St. Mary's Hospital)
Richmond, Virginia, United States
Virginia Beach General Hospital
Virginia Beach, Virginia, United States
Stevens Memorial Hospital
Edmonds, Washington, United States
Providence St. Peter Hospital
Olympia, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Theda Clark Medical Center
Neenah, Wisconsin, United States
Universitätsklinik Allgemeines
Vienna, Austria
Hopital Erasme
Brussels, Belgium
Service de Neurologie, Cliniques Universitaires St.-Luc
Brussels, Belgium
Dienst Neurologie UZ Gasthuisberg
Leuven, Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Universitätsklinikum Aachen, Neurologische Klinik
Aachen, Germany
Universität zu Köln klinik und poliklinik fur neurology
Cologne, Germany
University of Essen
Essen, Germany
Neurologische Universitätsklinik, Albert-Ludwigs-University
Freiburg im Breisgau, Germany
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
Hamburg-Eppendorf, Germany
Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
Homburg Saar, Germany
Friedrich-Schiller-University
Jena, Germany
Universitatklinikum Leipzig
Leipzig, Germany
Universitätsklinik Mainz
Mainz, Germany
Department of Neurology Klinikum
Minden, Germany
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
München, Germany
Neurologische Klinik Knappschafts - krankenhause
Recklinghausen, Germany
Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
Wiesbaden, Germany
Muelmed Hospital
Arcadia, South Africa
Bloemfontein Medi-Clinic
Bloemfontein, South Africa
Groote Schuur Hospital
Cape Town, South Africa
St. Augustine's Hospital
Durban, South Africa
Sandton Medi-Clinic
Johannesburg, South Africa
Pietermaritzburg Medi-Clinic
Pietermaritzburg, South Africa
Little Company of Mary Medical Centre
Pretoria, South Africa
Vergelegen Medi-Clinic
Somerset West, South Africa
Sunninghill Hospital
Sunninghill, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2002
First Posted
August 20, 2002
Study Start
December 1, 2000
Study Completion
January 1, 2003
Last Updated
April 3, 2006
Record last verified: 2006-03