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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Ischemic Attack, Transient

Cerebrovascular Stroke

Stroke, Acute

Cerebral Stroke

Treatments

Drug: NXY-059

Study type

Interventional

Funder types

Industry

Identifiers

NCT00061022

SA-NXY-0007

007

SAINT 2

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.