Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Phase 3
Completed
- Conditions
- Cerebral StrokeIschemic Attack, Transient
- Registration Number
- NCT00119626
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1700
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Global disability on modified Rankin scale at 90 days.
- Secondary Outcome Measures
Name Time Method NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
Trial Locations
- Locations (1)
Research Site
🇬🇧Glasgow, United Kingdom