A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

NCT ID: NCT00044070

Last Updated: 2006-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM872 (zonampanel)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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University of South Alabama Stroke Center

Mobile, Alabama, United States

Site Status

Phoenix Neurology Associates (Good Samaritan Hospital)

Phoenix, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

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Providence St. Joseph's Medical Center

Burbank, California, United States

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Grossmont Hospital

La Mesa, California, United States

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UCLA Emergency Medical Center

Los Angeles, California, United States

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Good Samaritan Hospital

San Jose, California, United States

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Santa Monica UCLA Medical Center

Santa Monica, California, United States

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John Muir Medical Center

Walnut Creek, California, United States

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Bridgeport Hospital

Bridgeport, Connecticut, United States

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Bethesda Memorial Hospital

Boynton Beach, Florida, United States

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Holmes Regional Medical Center

Melbourne, Florida, United States

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University of Miami (Jackson Memorial Hospital)

Miami, Florida, United States

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Florida Neurovascular Institute

Tampa, Florida, United States

Site Status

DNA Research (Dekalb Medical Center)

Decatur, Georgia, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

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Parkview Hospital

Fort Wayne, Indiana, United States

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University of Kentucky

Lexington, Kentucky, United States

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Louisville Neuroscience Research Center

Louisville, Kentucky, United States

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Cullicchia Neurology Clinic, LLP

Marrero, Louisiana, United States

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Johns Hopkins Medical Institute

Baltimore, Maryland, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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New England Medical Center

Boston, Massachusetts, United States

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Wayne State University

Detroit, Michigan, United States

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Michigan State University

East Lansing, Michigan, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

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Field Neurosciences Institute (St. Mary's Hospital)

Saginaw, Michigan, United States

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Advanced Neurology Specialists (Benefis Healthcare Hospital)

Great Falls, Montana, United States

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St. Patrick's Hospital & Health Sciences Center

Missoula, Montana, United States

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Washoe Comprehensive Stroke Center

Reno, Nevada, United States

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JFK Medical Center

Edison, New Jersey, United States

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Neurology Group of Bergen County (Valley Hospital)

Ridgewood, New Jersey, United States

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University of New Mexico Hospital

Albuquerque, New Mexico, United States

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VA Medical Center

Albuquerque, New Mexico, United States

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Albany Medical Center

Albany, New York, United States

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Buffalo General Hospital

Buffalo, New York, United States

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North Shore University Hospital

Manhasset, New York, United States

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Long Island Jewish Medical Center

New Hyde Park, New York, United States

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St. Luke's Hospital

New York, New York, United States

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Ellis Hospital

Schenectady, New York, United States

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Stony Brook Hospital

Stony Brook, New York, United States

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All-Trials Clinical Research, LLC (Rowan Regional Medical Center)

Winston-Salem, North Carolina, United States

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Metrohealth Medical Center

Cleveland, Ohio, United States

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Riverside Methodist Hospital

Columbus, Ohio, United States

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Medical College of Ohio

Toledo, Ohio, United States

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St. Elizabeth Health Center

Youngstown, Ohio, United States

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Hershey Medical Center

Hershey, Pennsylvania, United States

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University of Pittsburgh Medical Center Stroke Institute

Pittsburgh, Pennsylvania, United States

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Chattanooga Neurology Associates (Erlanger Hospital)

Chattanooga, Tennessee, United States

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Chattanooga Neurology Associates (Memorial Hospital)

Chattanooga, Tennessee, United States

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St. Thomas Hospital

Nashville, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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University of Texas (Houston Medical Center)

Houston, Texas, United States

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Neurology Associates, Inc. (St. Mary's Hospital)

Richmond, Virginia, United States

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Virginia Beach General Hospital

Virginia Beach, Virginia, United States

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Stevens Memorial Hospital

Edmonds, Washington, United States

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Providence St. Peter Hospital

Olympia, Washington, United States

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Sacred Heart Medical Center

Spokane, Washington, United States

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St. Luke's Medical Center

Milwaukee, Wisconsin, United States

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Theda Clark Medical Center

Neenah, Wisconsin, United States

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Universitätsklinik Allgemeines

Vienna, , Austria

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Hopital Erasme

Brussels, , Belgium

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Service de Neurologie, Cliniques Universitaires St.-Luc

Brussels, , Belgium

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Dienst Neurologie UZ Gasthuisberg

Leuven, , Belgium

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University of Alberta Hospital

Edmonton, Alberta, Canada

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Royal Jubilee Hospital

Victoria, British Columbia, Canada

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Toronto Western Hospital

Toronto, Ontario, Canada

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Universitätsklinikum Aachen, Neurologische Klinik

Aachen, , Germany

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Universität zu Köln klinik und poliklinik fur neurology

Cologne, , Germany

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University of Essen

Essen, , Germany

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Neurologische Universitätsklinik, Albert-Ludwigs-University

Freiburg im Breisgau, , Germany

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Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie

Hamburg-Eppendorf, , Germany

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Universitatklinikum Homburg, Neurologie Klinik und Poliklinik

Homburg Saar, , Germany

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Friedrich-Schiller-University

Jena, , Germany

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Universitatklinikum Leipzig

Leipzig, , Germany

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Universitätsklinik Mainz

Mainz, , Germany

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Department of Neurology Klinikum

Minden, , Germany

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Neurologische Klinik Klinikum Rechts der Isar der TU Munchen

München, , Germany

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Neurologische Klinik Knappschafts - krankenhause

Recklinghausen, , Germany

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Dr.-H.-Schmidt-Kliniken Ludwig-Erhar

Wiesbaden, , Germany

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Muelmed Hospital

Arcadia, , South Africa

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Bloemfontein Medi-Clinic

Bloemfontein, , South Africa

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Groote Schuur Hospital

Cape Town, , South Africa

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St. Augustine's Hospital

Durban, , South Africa

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Sandton Medi-Clinic

Johannesburg, , South Africa

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Pietermaritzburg Medi-Clinic

Pietermaritzburg, , South Africa

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Little Company of Mary Medical Centre

Pretoria, , South Africa

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Vergelegen Medi-Clinic

Somerset West, , South Africa

Site Status

Sunninghill Hospital

Sunninghill, , South Africa

Site Status

Countries

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United States Austria Belgium Canada Germany South Africa

Other Identifiers

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872-CL-003

Identifier Type: -

Identifier Source: org_study_id