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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


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.
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