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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00119626

Collaborator

(none)

1,700

Enrollment

Locations

20.1

Duration (Months)

850

Patients Per Site

42.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke Ischemic Attack, Transient	Drug: NXY-059	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

SAINT I (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke.

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Feb 1, 2005

Actual Study Completion Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

Global disability on modified Rankin scale at 90 days. []

Secondary Outcome Measures

NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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