Back to resultsSafety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Primary Purpose
Cerebral Stroke, Ischemic Attack, Transient
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, Acute, Cerebrovascular Stroke
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
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Global disability on modified Rankin scale at 90 days.
Secondary Outcome Measures
NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00119626
Brief Title
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Official Title
SAINT I (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
June 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Ischemic Attack, Transient
Keywords
Stroke, Acute, Cerebrovascular Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1700 (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 (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, 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
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
Facility Information:
Facility Name
Research Site
City
Södertälje
Country
Sweden
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
16467546
Citation
Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):588-600. doi: 10.1056/NEJMoa052980.
Results Reference
result
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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