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

This study has been completed.

First Received: July 6, 2005 Last Updated: March 18, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00119626

Purpose

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	Intervention	Phase
Cerebral Stroke Ischemic Attack, Transient	Drug: NXY-059	Phase III

MedlinePlus related topics: Transient Ischemic Attack

Drug Information available for: Disufenton sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment:	1700
Study Start Date:	June 2003
Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119626

Locations

Sweden
Research Site
Södertälje, Sweden
United Kingdom
Research Site
Glasgow, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca NXY-059 Medical Science Director, MD

AstraZeneca

More Information

Publications:

Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark 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):588-600.

Study ID Numbers:	SA-NXY-0006, 0006, SAINT I
Study First Received:	July 6, 2005
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00119626 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Stroke, Acute
Cerebrovascular Stroke

Study placed in the following topic categories:

Ischemic Attack, Transient
Antioxidants
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Disufenton sodium

Ischemia
Cardiovascular Agents
Brain Diseases
Cerebrovascular Disorders
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Ischemic Attack, Transient
Antioxidants
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Physiological Effects of Drugs
Stroke
Nervous System Diseases
Vascular Diseases
Disufenton sodium
Central Nervous System Diseases
Cardiovascular Agents

Ischemia
Brain Diseases
Protective Agents
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on May 07, 2009