Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Study Overview

• Status: Completed
• Conditions: Ischemic Attack, Transient; Stroke, Acute; Cerebral Stroke; Cerebrovascular Stroke
• Intervention / Treatment: Drug: NXY-059

• Study Type: Interventional
• Enrollment: 3200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Boulogne, Argentina
    • Research Site
  • Buenos Aires, Argentina
    • Research Site
  • Capital Federal, Argentina
    • Research Site
  • Ciudad de Buenos Aires, Argentina
    • Research Site
  • Cordoba, Argentina
    • Research Site
  • Mar del Plata, Argentina
    • Research Site
• Australia
  • Bedford Park, Australia
    • Research Site
  • Box Hill, Australia
    • Research Site
  • Camperdown, Australia
    • Research Site
  • Gosford, Australia
    • Research Site
  • Heidelberg, Australia
    • Research Site
  • New Lambton, Australia
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  • Parkville, Australia
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• Austria
  • Klosterneuburg, Austria
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  • Linz, Austria
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  • Salzburg, Austria
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  • Sankt Pölten, Austria
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  • Wien, Austria
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• Belgium
  • Antwerpen, Belgium
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  • Brugge, Belgium
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  • Leuven, Belgium
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• Brazil
  • Belo Horizonte, Brazil
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  • Curitiba, Brazil
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  • Goiânia, Brazil
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  • Porto Alegre, Brazil
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  • Rio de Janeiro, Brazil
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  • Sao Paulo, Brazil
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• Bulgaria
  • Pleven, Bulgaria
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  • Plovdiv, Bulgaria
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  • Russe, Bulgaria
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  • Sofia, Bulgaria
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  • Varna, Bulgaria
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• Canada
  • Barrie, Canada
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  • Calgary, Canada
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  • Edmonton, Canada
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  • Greenfield Park, Canada
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  • Halifax, Canada
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  • Kitchener, Canada
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  • Lethbridge, Canada
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  • Levis, Canada
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  • Mississauga, Canada
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  • Montreal, Canada
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  • Ottawa, Canada
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  • Penticton, Canada
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  • Quebec, Canada
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  • Saint John, Canada
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  • Saskatoon, Canada
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  • Thunder Bay, Canada
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  • Toronto, Canada
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  • Trois-Rivieres, Canada
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  • Vancouver, Canada
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  • Victoriaville, Canada
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  • Windsor, Canada
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• Chile
  • Santiago, Chile
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• China
  • Beijing, China
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  • Guang Zhou, China
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  • Shanghai, China
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• Czech Republic
  • Hradec Králové, Czech Republic
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  • Olomouc, Czech Republic
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  • Ostrava, Czech Republic
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  • Pardubice, Czech Republic
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  • Pelhrimov, Czech Republic
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  • Praha, Czech Republic
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• France
  • Belfort Cedex, France
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  • Besancon Cedex, France
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  • Bordeaux Cedex, France
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  • Bourg En Bresse, France
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  • Creteil, France
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  • Le Chesnay Cedex, France
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  • Lille, France
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  • MARSEILLE Cedex 5, France
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  • Montbeliard Cedex, France
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  • Montpellier Cedex 5, France
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  • Paris, France
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  • Paris Cedex 13, France
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  • Paris Cedex 18, France
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  • Perpignan, France
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  • Toulouse, France
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• Germany
  • Freiburg, Germany
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  • Hamburg, Germany
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  • Heidelberg, Germany
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  • Leipzig, Germany
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  • Minden, Germany
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  • Wiesbaden, Germany
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• Greece
  • Athens, Greece
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  • Heraklion, Greece
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  • Ioannina, Greece
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  • Thessaloniki, Greece
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• Hong Kong
  • Chai Wan, Hong Kong
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  • Hong Kong, Hong Kong
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• Hungary
  • Budapest, Hungary
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  • Debrecen, Hungary
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  • Gyor, Hungary
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  • Kistarcsa, Hungary
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• Israel
  • Ashkelon, Israel
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  • Beer-Sheva, Israel
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  • Hadera, Israel
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  • Haifa, Israel
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  • Holon, Israel
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  • Jerusalem, Israel
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  • Naharia, Israel
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  • Petach-Tikva, Israel
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  • Tel-Aviv, Israel
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  • Tel-Hashomer, Israel
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  • Zrifin, Israel
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• Korea, Republic of
  • Anyang, Korea, Republic of
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  • Seoul, Korea, Republic of
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• Mexico
  • Aguascalientes, Mexico
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  • Chihuahua, Mexico
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  • Guadalajara, Mexico
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  • Monterrey, Nuevo león, Mexico
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  • San Luis Potosí, Mexico
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  • Zapopan, Jalisco, Mexico
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• New Zealand
  • Grafton, New Zealand
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• Philippines
  • Manila, Philippines
    • Research Site
  • Pasay City, Philippines
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  • Quezon City, Philippines
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• Poland
  • Czestochowa, Poland
    • Research Site
  • Gdansk, Poland
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  • Katowice, Poland
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  • Kielce, Poland
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  • Kraków, Poland
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  • Lodz, Poland
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  • Lublin, Poland
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  • Opole, Poland
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  • Siedlce, Poland
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  • Szczecin, Poland
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  • Warszawa, Poland
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  • Zabrze, Poland
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• Portugal
  • Amadora, Portugal
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  • Coimbra, Portugal
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  • Lisboa, Portugal
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  • Porto, Portugal
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  • Setúbal, Portugal
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• Russian Federation
  • Moscow, Russian Federation
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  • St.Petersburg, Russian Federation
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• Slovakia
  • Lovoca, Slovakia
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  • Martin, Slovakia
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  • Nitra, Slovakia
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  • Ziliha, Slovakia
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• South Africa
  • Cape Town, South Africa
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  • George, South Africa
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  • Morningside, South Africa
    • Research Site
  • Somerset West, South Africa
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• Spain
  • Barcelona, Spain
    • Research Site
  • Gerona, Spain
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  • Madrid, Spain
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  • Santiago(A Coruña), Spain
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• Switzerland
  • Aarau, Switzerland
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  • Basel, Switzerland
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  • Bern, Switzerland
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  • Lausanne, Switzerland
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  • St. Gallen, Switzerland
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  • Zürich, Switzerland
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• Taiwan
  • Taichung, Taiwan
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  • Taipei, Taiwan
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  • Taoyuan Hsien, Taiwan
    • Research Site
• United Kingdom
  • Edinburgh, United Kingdom
    • Research Site
  • Glasgow, United Kingdom
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  • Newcastle-upon-Tyne, United Kingdom
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States
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  • Arkansas
    • Fort Smith, Arkansas, United States
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  • California
    • Arcadia, California, United States
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    • Concord, California, United States
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    • Englewood, California, United States
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    • La Mesa, California, United States
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    • LaJolla, California, United States
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    • Los Angeles, California, United States
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    • Oceanside, California, United States
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    • Palo Alto, California, United States
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    • Poway, California, United States
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    • Sacramento, California, United States
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    • San Diego, California, United States
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    • San Jose, California, United States
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  • Colorado
    • Englewood, Colorado, United States
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  • Connecticut
    • Danbury, Connecticut, United States
      • Research Site
    • Fairfield, Connecticut, United States
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  • Florida
    • Delray Beach, Florida, United States
      • Research Site
    • Fort Lauderdale, Florida, United States
      • Research Site
    • Lakeland, Florida, United States
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    • Lane Panama City, Florida, United States
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    • Melbourne, Florida, United States
      • Research Site
    • Naples, Florida, United States
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    • Ocala, Florida, United States
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    • Orlando, Florida, United States
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    • Port Charlotte, Florida, United States
      • Research Site
    • Sarasota, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • Weston, Florida, United States
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  • Georgia
    • Decatur, Georgia, United States
      • Research Site
    • Lithonia, Georgia, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
    • Des Plaines, Illinois, United States
      • Research Site
    • Elk Grove Village, Illinois, United States
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    • Maywood, Illinois, United States
      • Research Site
    • Oak Park, Illinois, United States
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  • Indiana
    • Fort Wayne, Indiana, United States
      • Research Site
  • Iowa
    • Cedar Rapids, Iowa, United States
      • Research Site
    • Des Moines, Iowa, United States
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  • Kentucky
    • Louisville, Kentucky, United States
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  • Louisiana
    • Marrero, Louisiana, United States
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  • Massachusetts
    • South Weymouth, Massachusetts, United States
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    • Worcester, Massachusetts, United States
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  • Michigan
    • Ann Arbor, Michigan, United States
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    • East Lansing, Michigan, United States
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    • Pontiac, Michigan, United States
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  • Minnesota
    • Golden Valley, Minnesota, United States
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  • Missouri
    • Kansas City, Missouri, United States
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    • Springfield, Missouri, United States
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  • Montana
    • Great Falls, Montana, United States
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  • Nebraska
    • Lincoln, Nebraska, United States
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  • Nevada
    • Reno, Nevada, United States
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  • New Jersey
    • Edison, New Jersey, United States
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    • Long Branch, New Jersey, United States
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    • Lumberton, New Jersey, United States
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    • Morristown, New Jersey, United States
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    • Neptune, New Jersey, United States
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    • Red Bank, New Jersey, United States
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    • Ridgewood, New Jersey, United States
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    • Summit, New Jersey, United States
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    • Toms River, New Jersey, United States
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    • Trenton, New Jersey, United States
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  • New York
    • Buffalo, New York, United States
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    • Flushing, New York, United States
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    • New Hyde, New York, United States
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    • Rochester, New York, United States
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    • Schenectady, New York, United States
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  • North Carolina
    • Asheville, North Carolina, United States
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    • Chapel Hill, North Carolina, United States
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    • Charlotte, North Carolina, United States
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    • Durham, North Carolina, United States
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    • Greensboro, North Carolina, United States
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    • Salisbury, North Carolina, United States
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    • Winston-Salem, North Carolina, United States
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  • Ohio
    • Cleveland, Ohio, United States
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    • Toledo, Ohio, United States
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    • Youngstown, Ohio, United States
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  • Oregon
    • Portland, Oregon, United States
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    • Tualatin, Oregon, United States
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  • Pennsylvania
    • Abington, Pennsylvania, United States
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    • Doylestown, Pennsylvania, United States
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    • Lancaster, Pennsylvania, United States
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    • Philadelphia, Pennsylvania, United States
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    • Pittsburgh, Pennsylvania, United States
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  • South Carolina
    • Beaufort, South Carolina, United States
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  • Tennessee
    • Bristol, Tennessee, United States
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    • Memphis, Tennessee, United States
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  • Texas
    • Houston, Texas, United States
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    • Lubbock, Texas, United States
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  • Virginia
    • Virginia Beach, Virginia, United States
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  • Washington
    • Olympia, Washington, United States
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    • Seattle, Washington, United States
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    • Tacoma, Washington, United States
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  • West Virginia
    • Charleston, West Virginia, United States
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  • Wisconsin
    • Madison, Wisconsin, United States
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    • Marshfield, Wisconsin, United States
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    • Milwaukee, Wisconsin, United States
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Participation Criteria

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:

• Males and females
• Acute ischemic stroke with limb weakness
• Onset of symptoms within 6 hours
• Full functional independence prior to the present stroke

Exclusion Criteria:

• Unconsciousness
• Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
• Severe illness with life expectancy less than 6 months.
• Known severe kidney disorder.
• Current known alcohol or illicit drug abuse or dependence.
• Pregnant or breast-feeding.
• Treatment with acetazolamide and methotrexate is not permitted during the infusion
• Participation in a previous clinical study within 30 days.
• Meets all other exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Global disability on modified Rankin scale at 90 days.

Secondary Outcome Measures

Outcome Measure
NIH stroke scale
Barthel Index
Stroke Impact Scale
EQ-5D all at 90 days
Safety outcomes

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (ACTUAL): September 1, 2006
• Study Completion (ACTUAL): September 1, 2006

Study Registration Dates

• First Submitted: May 20, 2003
• First Submitted That Met QC Criteria: May 20, 2003
• First Posted (ESTIMATE): May 21, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2010
• Last Update Submitted That Met QC Criteria: November 10, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Stroke; Ischemia; Hemorrhage; TIA; CVA; Transient Ischemic Attack; Cataplexy; cerebral vascular accident; Brain Attack
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Disufenton sodium
• Other Study ID Numbers: SA-NXY-0007; 007; SAINT 2