Overview

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