Back to resultsSafety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Primary Purpose
Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NXY-059
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke focused on measuring Stroke, cerebral vascular accident, CVA, Ischemia, Hemorrhage, TIA, Transient Ischemic Attack, Brain Attack, Cataplexy
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.
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Outcomes
Primary Outcome Measures
Global disability on modified Rankin scale at 90 days.
Secondary Outcome Measures
NIH stroke scale
Barthel Index
Stroke Impact Scale
EQ-5D all at 90 days
Safety outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00061022
Brief Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
Keywords
Stroke, cerebral vascular accident, CVA, Ischemia, Hemorrhage, TIA, Transient Ischemic Attack, Brain Attack, Cataplexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
3200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NXY-059
Primary Outcome Measure Information:
Title
Global disability on modified Rankin scale at 90 days.
Secondary Outcome Measure Information:
Title
NIH stroke scale
Title
Barthel Index
Title
Stroke Impact Scale
Title
EQ-5D all at 90 days
Title
Safety outcomes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca NXY-059 Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
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Birmingham
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Petach-Tikva
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
Country
Israel
Facility Name
Research Site
City
Tel-Hashomer
Country
Israel
Facility Name
Research Site
City
Zrifin
Country
Israel
Facility Name
Research Site
City
Anyang
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Chihuahua
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Monterrey, Nuevo león
Country
Mexico
Facility Name
Research Site
City
San Luis Potosí
Country
Mexico
Facility Name
Research Site
City
Zapopan, Jalisco
Country
Mexico
Facility Name
Research Site
City
Grafton
Country
New Zealand
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasay City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Czestochowa
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Opole
Country
Poland
Facility Name
Research Site
City
Siedlce
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Amadora
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Setúbal
Country
Portugal
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Lovoca
Country
Slovakia
Facility Name
Research Site
City
Martin
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Ziliha
Country
Slovakia
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
George
Country
South Africa
Facility Name
Research Site
City
Morningside
Country
South Africa
Facility Name
Research Site
City
Somerset West
Country
South Africa
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Gerona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Santiago(A Coruña)
Country
Spain
Facility Name
Research Site
City
Aarau
Country
Switzerland
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Lausanne
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
Country
Switzerland
Facility Name
Research Site
City
Zürich
Country
Switzerland
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan Hsien
Country
Taiwan
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Newcastle-upon-Tyne
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17687131
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.
Results Reference
derived
Learn more about this trial
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
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