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

Last updated: November 10, 2010
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Stroke

Occlusions

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT00119626
SA-NXY-0006
0006
SAINT I
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Unconsciousness

  • Subjects who are unlikely to complete the infusion of investigational product and/orare unlikely to undergo active medical management during that period due to a severeclinical 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

Study Design

Total Participants: 1700
Study Start date:
June 01, 2003
Estimated Completion Date:
February 28, 2005

Connect with a study center

  • Research Site

    Södertälje,
    Sweden

    Site Not Available

  • Research Site

    Södertälje,
    Sweden

    Site Not Available

  • Research Site

    Glasgow,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.