Cerebral StrokePhase 3NCT00061022

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

A Phase 3 study testing NXY-059 in people with Cerebral Stroke and Stroke, Acute, run by AstraZeneca at 256 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke
What is being tested?: NXY-059
How many people: 3,200 participants
Where: 256 sitesin 30 countries
Study dates: May 2003to Sep 2006
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

256 sites in 30 countries.

Country

City, postcode or hospital

256 sites in 30 countries

United States98 sites

Research Site
Abington, Pennsylvania
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Ann Arbor, Michigan
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Arcadia, California
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Asheville, North Carolina
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Beaufort, South Carolina
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Birmingham, Alabama
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Bristol, Tennessee
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Buffalo, New York
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Cedar Rapids, Iowa
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Chapel Hill, North Carolina
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Charleston, West Virginia
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Charlotte, North Carolina
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Chicago, Illinois
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Cleveland, Ohio
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Concord, California
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Danbury, Connecticut
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Decatur, Georgia
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Delray Beach, Florida
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Des Moines, Iowa
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Des Plaines, Illinois
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Doylestown, Pennsylvania
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Durham, North Carolina
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East Lansing, Michigan
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Edison, New Jersey
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Elk Grove Village, Illinois
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Englewood, California
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Englewood, Colorado
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Fairfield, Connecticut
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Flushing, New York
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Fort Lauderdale, Florida
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Fort Smith, Arkansas
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Fort Wayne, Indiana
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Golden Valley, Minnesota
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Great Falls, Montana
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Greensboro, North Carolina
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Houston, Texas
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Kansas City, Missouri
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La Jolla, California
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La Mesa, California
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Lakeland, Florida
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Lancaster, Pennsylvania
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Lane Panama City, Florida
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Lincoln, Nebraska
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Lithonia, Georgia
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Long Branch, New Jersey
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Los Angeles, California
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Louisville, Kentucky
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Lubbock, Texas
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Lumberton, New Jersey
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Madison, Wisconsin
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Marrero, Louisiana
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Marshfield, Wisconsin
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Maywood, Illinois
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Melbourne, Florida
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Memphis, Tennessee
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Milwaukee, Wisconsin
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Morristown, New Jersey
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Naples, Florida
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Neptune City, New Jersey
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New Hyde, New York
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Oak Park, Illinois
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Ocala, Florida
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Oceanside, California
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Olympia, Washington
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Orlando, Florida
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Palo Alto, California
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Pontiac, Michigan
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Port Charlotte, Florida
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Portland, Oregon
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Poway, California
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Red Bank, New Jersey
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Reno, Nevada
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Ridgewood, New Jersey
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Rochester, New York
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Sacramento, California
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Salisbury, North Carolina
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San Diego, California
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San Jose, California
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Sarasota, Florida
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Schenectady, New York
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Seattle, Washington
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South Weymouth, Massachusetts
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Springfield, Missouri
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Summit, New Jersey
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Tacoma, Washington
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Tampa, Florida
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Toledo, Ohio
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Toms River, New Jersey
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Trenton, New Jersey
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Tualatin, Oregon
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Virginia Beach, Virginia
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Weston, Florida
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Winston-Salem, North Carolina
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Worcester, Massachusetts
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Youngstown, Ohio

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Canada21 sites

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Barrie
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Calgary
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Edmonton
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Greenfield Park
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Halifax
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Kitchener
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Lethbridge
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Lévis
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Mississauga
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Montreal
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Ottawa
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Penticton
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Québec
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Saint John
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Saskatoon
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Thunder Bay
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Toronto
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Trois-Rivières
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Vancouver
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Victoriaville
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Windsor

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France13 sites

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Belfort
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Besançon
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Bordeaux
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Bourg-en-Bresse
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Créteil
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Le Chesnay
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Lille
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Marseille
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Montbéliard
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Montpellier
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Paris
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Perpignan
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Toulouse

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Poland12 sites

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Częstochowa
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Gdansk
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Katowice
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Kielce
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Krakow
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Lodz
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Lublin
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Opole
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Siedlce
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Szczecin
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Warsaw
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Zabrze

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Israel11 sites

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Ashkelon
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Beersheba
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Hadera
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Haifa
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Holon
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Jerusalem
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Nahariya
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Petah Tikva
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Tel Aviv
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Tel HaShomer
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Australia7 sites

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Bedford Park
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Box Hill
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Gosford
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Heidelberg
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New Lambton
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Parkville

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Argentina6 sites

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Boulogne Sur Mer
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Buenos Aires
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Capital Federal
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Ciudad de Buenos Aires
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Córdoba
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Mar del Plata

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Brazil6 sites

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Belo Horizonte
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Curitiba
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Goiânia
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Porto Alegre
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Rio de Janeiro
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São Paulo

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Czechia6 sites

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Hradec Králové
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Olomouc
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Ostrava
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Pardubice
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Pelhřimov
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Prague

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Germany6 sites

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Freiburg im Breisgau
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Hamburg
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Heidelberg
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Leipzig
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Minden
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Wiesbaden

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Mexico6 sites

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Aguascalientes
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Chihuahua City
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Guadalajara
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Monterrey, Nuevo León
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San Luis Potosí City
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Zapopan, Jalisco

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Switzerland6 sites

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Aarau
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Basel
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Bern
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Lausanne
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Sankt Gallen
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Zurich

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Austria5 sites

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Klosterneuburg
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Linz
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Salzburg
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Sankt Pölten
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Vienna

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Bulgaria5 sites

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Pleven
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Plovdiv
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Rousse
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Sofia
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Portugal5 sites

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Amadora
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Coimbra
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Lisbon
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Porto
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Greece4 sites

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Athens
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Heraklion
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Ioannina
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Hungary4 sites

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Budapest
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Debrecen
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Győr
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Slovakia4 sites

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Lovoca
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Martin
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South Africa4 sites

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George
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Spain4 sites

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Barcelona
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Girona
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Madrid
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Santiago(A Coruña)

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Belgium3 sites

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Antwerp
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Leuven

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China3 sites

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Shanghai

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Philippines3 sites

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Quezon City

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Taiwan3 sites

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Taichung
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Taipei
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United Kingdom3 sites

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Glasgow
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Hong Kong2 sites

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Russia2 sites

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South Korea2 sites

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Chile1 site

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New Zealand1 site

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About this study

Official title: 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

Conditions: Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
Being tested: NXY-059
Keywords: Stroke, cerebral vascular accident, CVA, Ischemia, Hemorrhage, TIA, Transient Ischemic Attack, Brain Attack, Cataplexy
Medical subject headings: Stroke, Ischemic Attack, Transient, Ischemia, Hemorrhage, Cataplexy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NXY-059Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Global disability on modified Rankin scale at 90 days.

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2003Sep 2006

First posted21 May 2003 (estimated)
Study startMay 2003
Primary completionSep 2006
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cerebral StrokeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Enrolment: 3,200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00061022
Sponsor's protocol ID: SA-NXY-0007
Other IDs: 007, SAINT 2
Status last verified: Nov 2010
First submitted: 20 May 2003
Last updated: 15 Nov 2010
Results posted: No

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.
PubMed 17687131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Cerebral Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00061022
Acronym / sponsor ID: SA-NXY-0007
Conditions: Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
Keywords: Stroke, cerebral vascular accident, CVA, Ischemia, Hemorrhage, TIA, Transient Ischemic Attack, Brain Attack
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,200 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 21 May 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NXY-059	Drug	–

Primary outcome

Global disability on modified Rankin scale at 90 days.

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
Derived from this study: PubMed 17687131Shuaib 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.

Related trials for Cerebral Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca NXY-059 Medical Science Director, MD study director

AstraZeneca

256 sites in 30 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NXY-059 in people with Cerebral Stroke and Stroke, Acute, run by AstraZeneca at 256 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, Canada, France, Poland, Israel and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global disability on modified Rankin scale at 90 days.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.