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

NCTId: NCT00044070

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

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.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years N/A False

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.

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

YM872 (zonampanel)

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Johns Hopkins Medical Institute
Baltimore, Maryland United States

Cullicchia Neurology Clinic, LLP
Marrero, Louisiana United States

Louisville Neuroscience Research Center
Louisville, Kentucky United States

University of Kentucky
Lexington, Kentucky United States

Parkview Hospital
Fort Wayne, Indiana United States

OSF St. Francis Medical Center
Peoria, Illinois United States

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

Florida Neurovascular Institute
Tampa, Florida United States

University of Miami (Jackson Memorial Hospital)
Miami, Florida United States

Holmes Regional Medical Center
Melbourne, Florida 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
Wien, Austria

Hopital Erasme
Brussels, Belgium

Service de Neurologie, Cliniques Universitaires St.-Luc
Bruxelles, Belgium

Dienst Neurologie UZ Gasthuisberg
Leuven, Belgium

University of Alberta Hospital
Edmonton, Alberta Canada

Royal Jubilee Hospital
Victoria, British Columbia Canada

Bethesda Memorial Hospital
Boynton Beach, Florida United States

Bridgeport Hospital
Bridgeport, Connecticut United States

John Muir Medical Center
Walnut Creek, California United States

Santa Monica UCLA Medical Center
Santa Monica, California United States

Good Samaritan Hospital
San Jose, California United States

UCLA Emergency Medical Center
Los Angeles, California United States

Grossmont Hospital
La Mesa, California United States

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

University of Arizona
Tucson, Arizona United States

Phoenix Neurology Associates (Good Samaritan Hospital)
Phoenix, Arizona United States

University of South Alabama Stroke Center
Mobile, Alabama United States

Michigan State University
East Lansing, Michigan United States

Wayne State University
Detroit, Michigan United States

Beth Israel Deaconess Medical Center
Boston, Massachusetts United States

New England Medical Center
Boston, Massachusetts 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

VA Medical Center
Albuquerque, New Mexico United States

University of New Mexico Hospital
Albuquerque, New Mexico United States

Toronto Western Hospital
Toronto, Ontario Canada

Universitätsklinikum Aachen, Neurologische Klinik
Aachen, Germany

University of Essen
Essen, Germany

Neurologische Universitätsklinik, Albert-Ludwigs-University
Freiburg, Germany

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

Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
Homburg Saar, Germany

Friedrich-Schiller-University
Jena, Germany

Universität zu Köln klinik und poliklinik fur neurology
Koln, Germany

Universitatklinikum Leipzig
Leipzig, Germany

Universitätsklinik Mainz
Mainz, Germany

Department of Neurology Klinikum
Minden, Germany

Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
Munchen, 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

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Cerebrovascular Accident

Other Related Condition Keywords

  1. Cerebral Infarction
  2. Stroke

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