Overview

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

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen 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.

- Meets all other exclusion criteria.