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

Stroke, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061022
• Other study ID #: SA-NXY-0007
• Secondary ID: 007SAINT 2
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2003
• Last updated: November 10, 2010
• Start date: May 2003
• Est. completion date: September 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Stroke
• Ischemia
• Ischemic Attack, Transient
• Stroke
• Stroke, Acute

Intervention

Drug:
• NXY-059

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Korea, Republic of,  Mexico,  New Zealand,  Philippines,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global disability on modified Rankin scale at 90 days.
Secondary	NIH stroke scale
Secondary	Barthel Index
Secondary	Stroke Impact Scale
Secondary	EQ-5D all at 90 days
Secondary	Safety outcomes