Clinical trial NCT00061022: Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Stroke
Stroke, Acute
Cerebrovascular Stroke
Ischemic Attack, Transient
Keywords: Stroke
cerebral vascular accident
CVA
Ischemia
Hemorrhage
TIA
Transient Ischemic Attack
Brain Attack
Cataplexy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-05-21
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global disability on modified Rankin scale at 90 days.
Secondary outcomes:
measure: NIH stroke scale
measure: Barthel Index
measure: Stroke Impact Scale
measure: EQ-5D all at 90 days
measure: Safety outcomes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Fort Smith
country: United States
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state: Arkansas
city: Arcadia
country: United States
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city: Concord
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city: Englewood
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city: La Mesa
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city: LaJolla
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country: Argentina
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country: Argentina
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country: Czech Republic
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country: France
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country: Mexico
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country: Mexico
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country: New Zealand
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country: Philippines
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city: Pasay City
country: Philippines
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country: Philippines
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city: Czestochowa
country: Poland
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city: Gdansk
country: Poland
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city: Katowice
country: Poland
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city: Kielce
country: Poland
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city: Kraków
country: Poland
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city: Lodz
country: Poland
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city: Lublin
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Siedlce
country: Poland
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city: Szczecin
country: Poland
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city: Warszawa
country: Poland
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city: Zabrze
country: Poland
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city: Amadora
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
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city: Porto
country: Portugal
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city: Setúbal
country: Portugal
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city: Moscow
country: Russian Federation
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city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Lovoca
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Ziliha
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
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city: George
country: South Africa
facility: Research Site
city: Morningside
country: South Africa
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city: Somerset West
country: South Africa
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city: Barcelona
country: Spain
facility: Research Site
city: Gerona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Santiago(A Coruña)
country: Spain
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan Hsien
country: Taiwan
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca NXY-059 Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.