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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Disufenton sodium

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