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A study to evaluate the effects of YM872 on stroke lesion volume in acute stroke patients



A study to evaluate the effects of YM872 on stroke lesion volume in acute stroke patients

For Condition: Cerebrovascular Accident
Status: Completed
Sponsor(s): Yamanouchi Pharma America ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

St. Elizabeth Health Center
Youngstown,  Ohio, 
United States
 

Wayne State University
Detroit,  Michigan, 
United States
 

Sacred Heart Medical Center
Spokane,  Washington, 
United States
 

Theda Clark Medical Center
Neenah,  Wisconsin, 
United States
 

University of Arizona
Tucson,  Arizona, 
United States
 

Department of Neurology Klinikum
Minden,  , 
Germany
 

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

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

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

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

Beth Israel Deaconess Medical Center
Boston,  Massachusetts, 
United States
 

Universitätsklinik Allgemeines
Wien,  , 
Austria
 

Neurology Group of Bergen County (Valley Hospital)
Ridgewood,  New Jersey, 
United States
 

Neurologische Klinik Knappschafts - krankenhause
Recklinghausen,  , 
Germany
 

Sunninghill Hospital
Sunninghill,,  , 
South Africa
 

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

Chattanooga Neurology Associates (Erlanger Hospital)
Chattanooga,  Tennessee, 
United States
 

Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
Wiesbaden,  , 
Germany
 

Field Neurosciences Institute (St. Mary's Hospital)
Saginaw,  Michigan, 
United States
 

Stevens Memorial Hospital
Edmonds,  Washington, 
United States
 

All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
Winston Salem,  North Carolina, 
United States
 

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

New England Medical Center
Boston,  Massachusetts, 
United States
 

Ellis Hospital
Schenectady,  New York, 
United States
 

Grossmont Hospital
La Mesa,  California, 
United States
 

JFK Medical Center
Edison,  New Jersey, 
United States
 

Friedrich-Schiller-University
Jena,  , 
Germany
 

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

Florida Neurovascular Institute
Tampa,  Florida, 
United States
 

Holmes Regional Medical Center
Melbourne,  Florida, 
United States
 

St. Patrick's Hospital & Health Sciences Center
Missoula,  Montana, 
United States
 

Hershey Medical Center
Hershey,  Pennsylvania, 
United States
 

University of Essen
ESSEN,  , 
Germany
 

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

Bloemfontein Medi-Clinic
Bloemfontein,  , 
South Africa
 

Vanderbilt University Medical Center
Nashville,  Tennessee, 
United States
 

Bridgeport Hospital
Bridgeport,  Connecticut, 
United States
 

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

Dienst Neurologie UZ Gasthuisberg
Leuven,  , 
Belgium
 

Good Samaritan Hospital
San Jose,  California, 
United States
 

University of Alberta Hospital
Edmonton,  Alberta, 
Canada
 

Toronto Western Hospital
Toronto,  Ontario, 
Canada
 

Universitatklinikum Leipzig
Leipzig,  , 
Germany
 

St. Thomas Hospital
Nashville,  Tennessee, 
United States
 

Louisville Neuroscience Research Center
Louisville,  Kentucky, 
United States
 

Advanced Neurology Specialists (Benefis Healthcare Hospital)
Great Falls,  Montana, 
United States
 

Michigan State University
East Lansing,  Michigan, 
United States
 

Providence St. Peter Hospital
Olympia,  Washington, 
United States
 

St. Augustine's Hospital
Durban,  , 
South Africa
 

Pietermaritzburg Medi-Clinic
PIETERMARITZBURG,  , 
South Africa
 

Chattanooga Neurology Associates (Memorial Hospital)
Chattanooga,  Tennessee, 
United States
 

Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
HOMBURG / SAAR,  , 
Germany
 

University of New Mexico Hospital
Albuquerque,  New Mexico, 
United States
 

Hopital Erasme
Brussels,  , 
Belgium
 

Neurologische Universitätsklinik, Albert-Ludwigs-University
Freiburg,  , 
Germany
 

Washoe Comprehensive Stroke Center
Reno,  Nevada, 
United States
 

Medical College of Ohio
Toledo,  Ohio, 
United States
 

Buffalo General Hospital
Buffalo,  New York, 
United States
 

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

William Beaumont Hospital
Royal Oak,  Michigan, 
United States
 

Royal Jubilee Hospital
Victoria,  British Columbia, 
Canada
 

Muelmed Hospital
Arcadia,  , 
South Africa
 

Metrohealth Medical Center
Cleveland,  Ohio, 
United States
 

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

Universitätsklinikum Aachen, Neurologische Klinik
Aachen,  , 
Germany
 

Cullicchia Neurology Clinic, LLP
Marrero,  Louisiana, 
United States
 

University of Kentucky
Lexington,  Kentucky, 
United States
 

University of Texas (Houston Medical Center)
Houston,  Texas, 
United States
 

North Shore University Hospital
Manhasset,  New York, 
United States
 

Little Company of Mary Medical Centre
Pretoria,  , 
South Africa
 

Bethesda Memorial Hospital
Boynton Beach,  Florida, 
United States
 

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

Stony Brook Hospital
Stony Brook,  New York, 
United States
 

Albany Medical Center
Albany,  New York, 
United States
 

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

John Muir Medical Center
Walnut Creek,  California, 
United States
 

UCLA Emergency Medical Center
Los Angeles,  California, 
United States
 

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

Sandton Medi-Clinic
Johannesburg,  , 
South Africa
 

Groote Schuur Hospital
Cape Town,  , 
South Africa
 

Riverside Methodist Hospital
Columbus,  Ohio, 
United States
 

Johns Hopkins Medical Institute
Baltimore,  Maryland, 
United States
 

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

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

Parkview Hospital
Ft. Wayne,  Indiana, 
United States
 

Universitätsklinik Mainz
Mainz,  , 
Germany
 

VA Medical Center
Albuquerque,  New Mexico, 
United States
 

Vergelegen Medi-Clinic
Somerset West,  , 
South Africa
 

Virginia Beach General Hospital
Virginia Beach,  Virginia, 
United States
 


Additional Information:
Study ID Numbers:
  872-CL-003; 
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044070

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