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

Cerebral Stroke Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119626
• Other study ID #: SA-NXY-0006
• Secondary ID: 0006SAINT I
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2005
• Last updated: November 10, 2010
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Stroke
• Ischemic Attack, Transient
• Stroke

Intervention

Drug:
• NXY-059

Locations

Country	Name	City	State
Sweden	Research Site	Södertälje
United Kingdom	Research Site	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

References & Publications (1)

Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hårdemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):58 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global disability on modified Rankin scale at 90 days.
Secondary	NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.