Status:
COMPLETED
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Lead Sponsor:
AstraZeneca
Conditions:
Cerebral Stroke
Ischemic Attack, Transient
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- Males and females
- Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
- Full functional independence prior to the present stroke
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
1700 Patients enrolled
Trial Details
Trial ID
NCT00119626
Start Date
June 1 2003
End Date
February 1 2005
Last Update
November 15 2010
Active Locations (2)
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1
Research Site
Södertälje, Sweden
2
Research Site
Glasgow, United Kingdom