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

This study has been completed.

First Received on May 20, 2003. Last Updated on November 10, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00061022

Purpose

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	SAINT (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

Resource links provided by NLM:

MedlinePlus related topics: Transient Ischemic Attack

Drug Information available for: Disufenton sodium

U.S. FDA Resources

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
Barthel Index
Stroke Impact Scale
EQ-5D all at 90 days
Safety outcomes

Estimated Enrollment:	3200
Study Start Date:	May 2003
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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.
Meets all other exclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061022

Show 258 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca NXY-059 Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71.

ClinicalTrials.gov Identifier:	NCT00061022 History of Changes
Other Study ID Numbers:	SA-NXY-0007, 007, SAINT 2
Study First Received:	May 20, 2003
Last Updated:	November 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Stroke
cerebral vascular accident
CVA
Ischemia
Hemorrhage

TIA
Transient Ischemic Attack
Brain Attack
Cataplexy

Additional relevant MeSH terms:

Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

Pathologic Processes
Brain Infarction
Disufenton sodium
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012