Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Phase 2
Completed
- Conditions
- Intracerebral Hemorrhage
- Registration Number
- NCT00075959
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- Males and females
- Intracerebral Hemorrhage as the cause of stroke symptoms
- 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 7 days.
- Meets all other exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Global disability on modified Rankin scale at 90 days
- Secondary Outcome Measures
Name Time Method NIH stroke scale Barthel Index Stroke Impact Scale
Trial Locations
- Locations (1)
Research Site
🇺🇸Marshfield, Wisconsin, United States