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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00044070
Collaborator
Astellas Pharma US, Inc. (Industry)
89
Locations
25
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: YM872 (zonampanel)
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
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
Study Start Date :
Dec 1, 2000
Study Completion Date :
Jan 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Stroke Center Mobile Alabama United States
    2 Phoenix Neurology Associates (Good Samaritan Hospital) Phoenix Arizona United States
    3 University of Arizona Tucson Arizona United States
    4 Providence St. Joseph's Medical Center Burbank California United States
    5 Grossmont Hospital La Mesa California United States
    6 UCLA Emergency Medical Center Los Angeles California United States
    7 Good Samaritan Hospital San Jose California United States
    8 Santa Monica UCLA Medical Center Santa Monica California United States
    9 John Muir Medical Center Walnut Creek California United States
    10 Bridgeport Hospital Bridgeport Connecticut United States
    11 Bethesda Memorial Hospital Boynton Beach Florida United States
    12 Holmes Regional Medical Center Melbourne Florida United States
    13 University of Miami (Jackson Memorial Hospital) Miami Florida United States
    14 Florida Neurovascular Institute Tampa Florida United States
    15 DNA Research (Dekalb Medical Center) Decatur Georgia United States
    16 OSF St. Francis Medical Center Peoria Illinois United States
    17 Parkview Hospital Fort Wayne Indiana United States
    18 University of Kentucky Lexington Kentucky United States
    19 Louisville Neuroscience Research Center Louisville Kentucky United States
    20 Cullicchia Neurology Clinic, LLP Marrero Louisiana United States
    21 Johns Hopkins Medical Institute Baltimore Maryland United States
    22 Beth Israel Deaconess Medical Center Boston Massachusetts United States
    23 New England Medical Center Boston Massachusetts United States
    24 Wayne State University Detroit Michigan United States
    25 Michigan State University East Lansing Michigan United States
    26 William Beaumont Hospital Royal Oak Michigan United States
    27 Field Neurosciences Institute (St. Mary's Hospital) Saginaw Michigan United States
    28 Advanced Neurology Specialists (Benefis Healthcare Hospital) Great Falls Montana United States
    29 St. Patrick's Hospital & Health Sciences Center Missoula Montana United States
    30 Washoe Comprehensive Stroke Center Reno Nevada United States
    31 JFK Medical Center Edison New Jersey United States
    32 Neurology Group of Bergen County (Valley Hospital) Ridgewood New Jersey United States
    33 University of New Mexico Hospital Albuquerque New Mexico United States
    34 VA Medical Center Albuquerque New Mexico United States
    35 Albany Medical Center Albany New York United States
    36 Buffalo General Hospital Buffalo New York United States
    37 North Shore University Hospital Manhasset New York United States
    38 Long Island Jewish Medical Center New Hyde Park New York United States
    39 St. Luke's Hospital New York New York United States
    40 Ellis Hospital Schenectady New York United States
    41 Stony Brook Hospital Stony Brook New York United States
    42 All-Trials Clinical Research, LLC (Rowan Regional Medical Center) Winston-Salem North Carolina United States
    43 Metrohealth Medical Center Cleveland Ohio United States
    44 Riverside Methodist Hospital Columbus Ohio United States
    45 Medical College of Ohio Toledo Ohio United States
    46 St. Elizabeth Health Center Youngstown Ohio United States
    47 Hershey Medical Center Hershey Pennsylvania United States
    48 University of Pittsburgh Medical Center Stroke Institute Pittsburgh Pennsylvania United States
    49 Chattanooga Neurology Associates (Erlanger Hospital) Chattanooga Tennessee United States
    50 Chattanooga Neurology Associates (Memorial Hospital) Chattanooga Tennessee United States
    51 St. Thomas Hospital Nashville Tennessee United States
    52 Vanderbilt University Medical Center Nashville Tennessee United States
    53 University of Texas (Houston Medical Center) Houston Texas United States
    54 Neurology Associates, Inc. (St. Mary's Hospital) Richmond Virginia United States
    55 Virginia Beach General Hospital Virginia Beach Virginia United States
    56 Stevens Memorial Hospital Edmonds Washington United States
    57 Providence St. Peter Hospital Olympia Washington United States
    58 Sacred Heart Medical Center Spokane Washington United States
    59 St. Luke's Medical Center Milwaukee Wisconsin United States
    60 Theda Clark Medical Center Neenah Wisconsin United States
    61 Universitätsklinik Allgemeines Wien Austria
    62 Hopital Erasme Brussels Belgium
    63 Service de Neurologie, Cliniques Universitaires St.-Luc Bruxelles Belgium
    64 Dienst Neurologie UZ Gasthuisberg Leuven Belgium
    65 University of Alberta Hospital Edmonton Alberta Canada
    66 Royal Jubilee Hospital Victoria British Columbia Canada
    67 Toronto Western Hospital Toronto Ontario Canada
    68 Universitätsklinikum Aachen, Neurologische Klinik Aachen Germany
    69 University of Essen Essen Germany
    70 Neurologische Universitätsklinik, Albert-Ludwigs-University Freiburg Germany
    71 Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie Hamburg-Eppendorf Germany
    72 Universitatklinikum Homburg, Neurologie Klinik und Poliklinik Homburg Saar Germany
    73 Friedrich-Schiller-University Jena Germany
    74 Universität zu Köln klinik und poliklinik fur neurology Koln Germany
    75 Universitatklinikum Leipzig Leipzig Germany
    76 Universitätsklinik Mainz Mainz Germany
    77 Department of Neurology Klinikum Minden Germany
    78 Neurologische Klinik Klinikum Rechts der Isar der TU Munchen Munchen Germany
    79 Neurologische Klinik Knappschafts - krankenhause Recklinghausen Germany
    80 Dr.-H.-Schmidt-Kliniken Ludwig-Erhar Wiesbaden Germany
    81 Muelmed Hospital Arcadia South Africa
    82 Bloemfontein Medi-Clinic Bloemfontein South Africa
    83 Groote Schuur Hospital Cape Town South Africa
    84 St. Augustine's Hospital Durban South Africa
    85 Sandton Medi-Clinic Johannesburg South Africa
    86 Pietermaritzburg Medi-Clinic Pietermaritzburg South Africa
    87 Little Company of Mary Medical Centre Pretoria South Africa
    88 Vergelegen Medi-Clinic Somerset West South Africa
    89 Sunninghill Hospital Sunninghill South Africa

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma US, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00044070
    Other Study ID Numbers:
    • 872-CL-003
    First Posted:
    Aug 20, 2002
    Last Update Posted:
    Apr 3, 2006
    Last Verified:
    Mar 1, 2006
    Keywords provided by , ,
    ARTIST
    Acute ischemic stroke
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Apr 3, 2006