Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke


Phase 3 Results

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