Back to resultsA Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM872 (zonampanel)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring ARTIST, Acute ischemic stroke
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Other exclusion criteria as specified by the study protocol.
Sites / Locations
- University of South Alabama Stroke Center
- Phoenix Neurology Associates (Good Samaritan Hospital)
- University of Arizona
- Providence St. Joseph's Medical Center
- Grossmont Hospital
- UCLA Emergency Medical Center
- Good Samaritan Hospital
- Santa Monica UCLA Medical Center
- John Muir Medical Center
- Bridgeport Hospital
- Bethesda Memorial Hospital
- Holmes Regional Medical Center
- University of Miami (Jackson Memorial Hospital)
- Florida Neurovascular Institute
- DNA Research (Dekalb Medical Center)
- OSF St. Francis Medical Center
- Parkview Hospital
- University of Kentucky
- Louisville Neuroscience Research Center
- Cullicchia Neurology Clinic, LLP
- Johns Hopkins Medical Institute
- Beth Israel Deaconess Medical Center
- New England Medical Center
- Wayne State University
- Michigan State University
- William Beaumont Hospital
- Field Neurosciences Institute (St. Mary's Hospital)
- Advanced Neurology Specialists (Benefis Healthcare Hospital)
- St. Patrick's Hospital & Health Sciences Center
- Washoe Comprehensive Stroke Center
- JFK Medical Center
- Neurology Group of Bergen County (Valley Hospital)
- University of New Mexico Hospital
- VA Medical Center
- Albany Medical Center
- Buffalo General Hospital
- North Shore University Hospital
- Long Island Jewish Medical Center
- St. Luke's Hospital
- Ellis Hospital
- Stony Brook Hospital
- All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
- Metrohealth Medical Center
- Riverside Methodist Hospital
- Medical College of Ohio
- St. Elizabeth Health Center
- Hershey Medical Center
- University of Pittsburgh Medical Center Stroke Institute
- Chattanooga Neurology Associates (Erlanger Hospital)
- Chattanooga Neurology Associates (Memorial Hospital)
- St. Thomas Hospital
- Vanderbilt University Medical Center
- University of Texas (Houston Medical Center)
- Neurology Associates, Inc. (St. Mary's Hospital)
- Virginia Beach General Hospital
- Stevens Memorial Hospital
- Providence St. Peter Hospital
- Sacred Heart Medical Center
- St. Luke's Medical Center
- Theda Clark Medical Center
- Universitätsklinik Allgemeines
- Hopital Erasme
- Service de Neurologie, Cliniques Universitaires St.-Luc
- Dienst Neurologie UZ Gasthuisberg
- University of Alberta Hospital
- Royal Jubilee Hospital
- Toronto Western Hospital
- Universitätsklinikum Aachen, Neurologische Klinik
- University of Essen
- Neurologische Universitätsklinik, Albert-Ludwigs-University
- Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
- Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
- Friedrich-Schiller-University
- Universität zu Köln klinik und poliklinik fur neurology
- Universitatklinikum Leipzig
- Universitätsklinik Mainz
- Department of Neurology Klinikum
- Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
- Neurologische Klinik Knappschafts - krankenhause
- Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
- Muelmed Hospital
- Bloemfontein Medi-Clinic
- Groote Schuur Hospital
- St. Augustine's Hospital
- Sandton Medi-Clinic
- Pietermaritzburg Medi-Clinic
- Little Company of Mary Medical Centre
- Vergelegen Medi-Clinic
- Sunninghill Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00044070
First Posted
August 16, 2002
Last Updated
March 31, 2006
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00044070
Brief Title
A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
ARTIST, Acute ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM872 (zonampanel)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Other exclusion criteria as specified by the study protocol.
Facility Information:
Facility Name
University of South Alabama Stroke Center
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Phoenix Neurology Associates (Good Samaritan Hospital)
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Providence St. Joseph's Medical Center
City
Burbank
State/Province
California
Country
United States
Facility Name
Grossmont Hospital
City
La Mesa
State/Province
California
Country
United States
Facility Name
UCLA Emergency Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
Country
United States
Facility Name
Santa Monica UCLA Medical Center
City
Santa Monica
State/Province
California
Country
United States
Facility Name
John Muir Medical Center
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
University of Miami (Jackson Memorial Hospital)
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida Neurovascular Institute
City
Tampa
State/Province
Florida
Country
United States
Facility Name
DNA Research (Dekalb Medical Center)
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Louisville Neuroscience Research Center
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Cullicchia Neurology Clinic, LLP
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Johns Hopkins Medical Institute
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
New England Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Field Neurosciences Institute (St. Mary's Hospital)
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Advanced Neurology Specialists (Benefis Healthcare Hospital)
City
Great Falls
State/Province
Montana
Country
United States
Facility Name
St. Patrick's Hospital & Health Sciences Center
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Washoe Comprehensive Stroke Center
City
Reno
State/Province
Nevada
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Neurology Group of Bergen County (Valley Hospital)
City
Ridgewood
State/Province
New Jersey
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
VA Medical Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Buffalo General Hospital
City
Buffalo
State/Province
New York
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
St. Luke's Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
Ellis Hospital
City
Schenectady
State/Province
New York
Country
United States
Facility Name
Stony Brook Hospital
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Medical College of Ohio
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
St. Elizabeth Health Center
City
Youngstown
State/Province
Ohio
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center Stroke Institute
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Chattanooga Neurology Associates (Erlanger Hospital)
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Chattanooga Neurology Associates (Memorial Hospital)
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
University of Texas (Houston Medical Center)
City
Houston
State/Province
Texas
Country
United States
Facility Name
Neurology Associates, Inc. (St. Mary's Hospital)
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Beach General Hospital
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Stevens Memorial Hospital
City
Edmonds
State/Province
Washington
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Theda Clark Medical Center
City
Neenah
State/Province
Wisconsin
Country
United States
Facility Name
Universitätsklinik Allgemeines
City
Wien
Country
Austria
Facility Name
Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
Service de Neurologie, Cliniques Universitaires St.-Luc
City
Bruxelles
Country
Belgium
Facility Name
Dienst Neurologie UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Universitätsklinikum Aachen, Neurologische Klinik
City
Aachen
Country
Germany
Facility Name
University of Essen
City
Essen
Country
Germany
Facility Name
Neurologische Universitätsklinik, Albert-Ludwigs-University
City
Freiburg
Country
Germany
Facility Name
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
City
Hamburg-Eppendorf
Country
Germany
Facility Name
Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
City
Homburg Saar
Country
Germany
Facility Name
Friedrich-Schiller-University
City
Jena
Country
Germany
Facility Name
Universität zu Köln klinik und poliklinik fur neurology
City
Koln
Country
Germany
Facility Name
Universitatklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinik Mainz
City
Mainz
Country
Germany
Facility Name
Department of Neurology Klinikum
City
Minden
Country
Germany
Facility Name
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
City
Munchen
Country
Germany
Facility Name
Neurologische Klinik Knappschafts - krankenhause
City
Recklinghausen
Country
Germany
Facility Name
Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
City
Wiesbaden
Country
Germany
Facility Name
Muelmed Hospital
City
Arcadia
Country
South Africa
Facility Name
Bloemfontein Medi-Clinic
City
Bloemfontein
Country
South Africa
Facility Name
Groote Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
St. Augustine's Hospital
City
Durban
Country
South Africa
Facility Name
Sandton Medi-Clinic
City
Johannesburg
Country
South Africa
Facility Name
Pietermaritzburg Medi-Clinic
City
Pietermaritzburg
Country
South Africa
Facility Name
Little Company of Mary Medical Centre
City
Pretoria
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
Country
South Africa
Facility Name
Sunninghill Hospital
City
Sunninghill
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
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