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

March 31, 2006 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Universitätsklinik Allgemeines
  • Belgium
      • Brussels, Belgium
        • Hopital Erasme
      • Bruxelles, Belgium
        • Service de Neurologie, Cliniques Universitaires St.-Luc
      • Leuven, Belgium
        • Dienst Neurologie UZ Gasthuisberg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Western Hospital
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen, Neurologische Klinik
      • Essen, Germany
        • University of Essen
      • Freiburg, Germany
        • Neurologische Universitätsklinik, Albert-Ludwigs-University
      • Hamburg-Eppendorf, Germany
        • Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
      • Homburg Saar, Germany
        • Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
      • Jena, Germany
        • Friedrich-Schiller-University
      • Koln, Germany
        • Universität zu Köln klinik und poliklinik fur neurology
      • Leipzig, Germany
        • Universitätklinikum Leipzig
      • Mainz, Germany
        • Universitatsklinik Mainz
      • Minden, Germany
        • Department of Neurology Klinikum
      • Munchen, Germany
        • Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
      • Recklinghausen, Germany
        • Neurologische Klinik Knappschafts - krankenhause
      • Wiesbaden, Germany
        • Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
  • South Africa
      • Arcadia, South Africa
        • Muelmed Hospital
      • Bloemfontein, South Africa
        • Bloemfontein Medi-Clinic
      • Cape Town, South Africa
        • Groote Schuur Hospital
      • Durban, South Africa
        • St. Augustine's Hospital
      • Johannesburg, South Africa
        • Sandton Medi-Clinic
      • Pietermaritzburg, South Africa
        • Pietermaritzburg Medi-Clinic
      • Pretoria, South Africa
        • Little Company of Mary Medical Centre
      • Somerset West, South Africa
        • Vergelegen Medi-Clinic
      • Sunninghill, South Africa
        • Sunninghill Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States
        • University of South Alabama Stroke Center
    • Arizona
      • Phoenix, Arizona, United States
        • Phoenix Neurology Associates (Good Samaritan Hospital)
      • Tucson, Arizona, United States
        • University of Arizona
    • California
      • Burbank, California, United States
        • Providence St. Joseph's Medical Center
      • La Mesa, California, United States
        • Grossmont Hospital
      • Los Angeles, California, United States
        • UCLA Emergency Medical Center
      • San Jose, California, United States
        • Good Samaritan Hospital
      • Santa Monica, California, United States
        • Santa Monica UCLA Medical Center
      • Walnut Creek, California, United States
        • John Muir Medical Center
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Bridgeport Hospital
    • Florida
      • Boynton Beach, Florida, United States
        • Bethesda Memorial Hospital
      • Melbourne, Florida, United States
        • Holmes Regional Medical Center
      • Miami, Florida, United States
        • University of Miami (Jackson Memorial Hospital)
      • Tampa, Florida, United States
        • Florida Neurovascular Institute
    • Georgia
      • Decatur, Georgia, United States
        • DNA Research (Dekalb Medical Center)
    • Illinois
      • Peoria, Illinois, United States
        • OSF St. Francis Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States
        • Parkview Hospital
    • Kentucky
      • Lexington, Kentucky, United States
        • University of Kentucky
      • Louisville, Kentucky, United States
        • Louisville Neuroscience Research Center
    • Louisiana
      • Marrero, Louisiana, United States
        • Cullicchia Neurology Clinic, LLP
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Medical Institute
    • Massachusetts
      • Boston, Massachusetts, United States
        • New England Medical Center
      • Boston, Massachusetts, United States
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Wayne State University
      • East Lansing, Michigan, United States
        • Michigan State University
      • Royal Oak, Michigan, United States
        • William Beaumont Hospital
      • Saginaw, Michigan, United States
        • Field Neurosciences Institute (St. Mary's Hospital)
    • Montana
      • Great Falls, Montana, United States
        • Advanced Neurology Specialists (Benefis Healthcare Hospital)
      • Missoula, Montana, United States
        • St. Patrick's Hospital & Health Sciences Center
    • Nevada
      • Reno, Nevada, United States
        • Washoe Comprehensive Stroke Center
    • New Jersey
      • Edison, New Jersey, United States
        • JFK Medical Center
      • Ridgewood, New Jersey, United States
        • Neurology Group of Bergen County (Valley Hospital)
    • New Mexico
      • Albuquerque, New Mexico, United States
        • University of New Mexico Hospital
      • Albuquerque, New Mexico, United States
        • VA Medical Center
    • New York
      • Albany, New York, United States
        • Albany Medical Center
      • Buffalo, New York, United States
        • Buffalo General Hospital
      • Manhasset, New York, United States
        • North Shore University Hospital
      • New Hyde Park, New York, United States
        • Long Island Jewish Medical Center
      • New York, New York, United States
        • St. Luke's Hospital
      • Schenectady, New York, United States
        • Ellis Hospital
      • Stony Brook, New York, United States
        • Stony Brook Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
    • Ohio
      • Cleveland, Ohio, United States
        • MetroHealth Medical Center
      • Columbus, Ohio, United States
        • Riverside Methodist Hospital
      • Toledo, Ohio, United States
        • Medical College of Ohio
      • Youngstown, Ohio, United States
        • St. Elizabeth Health Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center Stroke Institute
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Chattanooga Neurology Associates (Erlanger Hospital)
      • Chattanooga, Tennessee, United States
        • Chattanooga Neurology Associates (Memorial Hospital)
      • Nashville, Tennessee, United States
        • St. Thomas Hospital
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States
        • University of Texas (Houston Medical Center)
    • Virginia
      • Richmond, Virginia, United States
        • Neurology Associates, Inc. (St. Mary's Hospital)
      • Virginia Beach, Virginia, United States
        • Virginia Beach General Hospital
    • Washington
      • Edmonds, Washington, United States
        • Stevens Memorial Hospital
      • Olympia, Washington, United States
        • Providence St. Peter Hospital
      • Spokane, Washington, United States
        • Sacred Heart Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • St. Luke's Medical Center
      • Neenah, Wisconsin, United States
        • Theda Clark Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

August 16, 2002

First Submitted That Met QC Criteria

August 19, 2002

First Posted (ESTIMATE)

August 20, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

April 3, 2006

Last Update Submitted That Met QC Criteria

March 31, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 872-CL-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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