A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Condition(s) targeted: Acute Ischemic Stroke

Intervention: YM872 (zonampanel), t-PA (alteplase) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Inc

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.

Official title: A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo

Study design: Treatment, Randomized, Double-Blind, Placebo Control

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with acute ischemic stroke who are treated with alteplase within 3 hours of

stroke onset (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 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.

- 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.

- Other criteria as specified in the study protocol

Exclusion Criteria:

- Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain

hemorrhage, risk for hemorrhage, or other criteria.

- Patients who have stroke of the brainstem or cerebellum.

- 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

Universitätsklinik allgemeines Krankenhaus der Stadt Wien, Wien, Austria

Dienst Neurologie UZ Gasthuisberg, Leuven, Belgium

Friedrich-Schiller-University, Jena, Germany

Neurologische Klinik Klinikum Rechts der Isar der TU Munchen, Munchen, Germany

Neurologische Klinik Knappschafts - krankenhause, Recklinghausen, Germany

Neurologische Universitätsklinik, Freiburg, Germany

Universität zu Köln klinik und poliklinik fur neurology, Köln, Germany

Universitätsklinik Mainz, Mainz, Germany

Universitätsklinikum Aachen, Neurologische Klinik, Aachen, Germany

Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie, Hamburg-Eppendorf, Germany

University Essen, Essen, Germany

Universitätsklinikum Leipzig, Leipzig, Germany

Neurology Klinik Klinikum Hanover, Hanover, Germany

Neurologisch Psychiayrische Klinik, Weisbaden, Germany

University of South Alabama Stroke Center, Mobile, Alabama, United States

University of Alberta Hospital, Edmonton, Alberta, Canada

Foothills Medical Centre, Calgary, Alberta, Canada

University of Arizona, Tucson, Arizona, United States

Good Samaritan Hospital, Phoenix, Arizona, United States

Royal Jubilee Hospital, Victoria, British Columbia, Canada

Victoria General Hospital, Victoria, British Columbia, Canada

Vancouver General Hospital, Vancouver, British Columbia, Canada

Penticton Regional Hospital, Penticton, British Columbia, Canada

Good Samaritan Hospital, San Jose, California, United States

Grossmont Hospital, La Mesa, California, United States

John Muir Medical Center, Walnut Creek, California, United States

Providence St. Joseph's Medical Center, Burbank, California, United States

Tri-City Medical Center, Oceanside, California, United States

Scripps Memorial Hospital, Encinitas, California, United States

Stanford University Medical Center, Palo Alto, California, United States

East Bay Region Associates in Neurology, Berkeley, California, United States

Mt Diablo Medical Center, Walnut Creek, California, United States

University of California at San Diego, San Diego, California, United States

Mercy San Juan Hospital, Carmichael, California, United States

Mercy General Hospital, Sacramento, California, United States

Scripps Mercy Hospital, San Diego, California, United States

University of California Davis Medical Center, Davis, California, United States

UCLA Medical Center, Los Angeles, California, United States

UCLA Medical Center - Santa Monica, Santa Monica, California, United States

Colorado Neurological Institute, Englewood, Colorado, United States

Bridgeport Hospital, Bridgeport, Connecticut, United States

Bay Medical Center, Panama City, Florida, United States

Bethesda Memorial Hospital, Boynton Beach, Florida, United States

Holmes Regional Medical Center, Melbourne, Florida, United States

Tampa General Hospital, Tampa, Florida, United States

St Joseph's Hospital, Tampa, Florida, United States

Columbia JFK Hospital, Atlantis, Florida, United States

Lakeland Regional Medical Center, Lakeland, Florida, United States

DNA Research (Dekalb Medical Center), Decatur, Georgia, United States

St Joseph Hospital, Savannah, Georgia, United States

Candler Hospital, Savannah, Georgia, United States

St Francis Hospital, Columbus, Georgia, United States

Queen's Medical Center, Honolulu, Hawaii, United States

OSF St. Francis Medical Center, Peoria, Illinois, United States

Parkview Hospital, Fort Wayne, Indiana, United States

Methodist Hospital, Indianapolis, Indiana, United States

Louisville Neuroscience Research Center, Louisville, Kentucky, United States

Culicchia Neurology Clinic, LLP, Marrero, Louisiana, United States

University of Maryland Medical System, Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

New England Medical Center, Boston, Massachusetts, United States

Michigan State University, East Lansing, Michigan, United States

William Beaumont Hospital, Royal Oak, Michigan, United States

Northern Michigan Neurology, Traverse City, Michigan, United States

St John's Hospital, Detroit, Michigan, United States

Bi-County Hospital, Warren, Michigan, United States

Research Medical Center, Kansas City, Missouri, United States

Advanced Neurology Specialists (Benefis Healthcare Hospital), Great Falls, 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

Muhlenberg Regional Medical Center, Plainfield, 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

Ellis Hospital, Schenectady, New York, United States

Long Island Jewish Medical Center, New Hyde Park, New York, United States

North Shore University Hospital, Manhasset, New York, United States

St. Luke's Hospital, New York, New York, United States

Stony Brook Hospital, Stony Brook, New York, United States

Columbia Presbyterian Medical Center, New York, New York, United States

Rochester General Hospital, Rochester, New York, United States

Roosevelt Hospital, New York, New York, United States

Rowan Regional Medical Center, Winston-Salem, North Carolina, United States

Forsyth Medical Center, Winston-Salem, North Carolina, United States

Medical College of Ohio, Toledo, Ohio, United States

Metrohealth Medical Center, Cleveland, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

St. Elizabeth Health Center, Youngstown, Ohio, United States

Akron General Medical Center, Akron, Ohio, United States

Hershey Medical Center, Hershey, Pennsylvania, United States

University of Pittsburgh Medical Center Stroke Institute, Pittsburgh, Pennsylvania, United States

University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States

Crozer Chester Medical Center, Upland, Pennsylvania, United States

Westmoreland Regional Hospital, Greensburg, Pennsylvania, United States

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Charles LeMoyne Hospital, Greenfield Park, Quebec, Canada

Pavillion St Joseph, Trois Rivers, Quebec, Canada

Notre-Dame Hospital, Montreal, Quebec, Canada

Miriam Hospital, Providence, Rhode Island, United States

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Roper Hospital, Charleston, South Carolina, 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

Neurological Research Center, Inc, Bennington, Vermont, United States

Neurology Associates, Inc. (St. Mary's Hospital), Richmond, Virginia, United States

Virginia Beach General Hospital, Virginia Beach, Virginia, United States

Providence St. Peter Hospital, Olympia, Washington, United States

Stevens Memorial Hospital, Edmonds, Washington, United States

St. Luke's Medical Center, Milwaukee, Wisconsin, United States

Theda Clark Medical Center, Neenah, Wisconsin, United States

Starting date: December 2000
Ending date: January 2003
Last updated: March 31, 2006