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

Tracking Information

First Received Date ^ICMJE

May 20, 2003

Last Updated Date

March 18, 2009

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Global disability on modified Rankin scale at 90 days.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00061022 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cerebral Stroke
Stroke, Acute
Cerebrovascular Stroke
Ischemic Attack, Transient

Intervention ^ICMJE

Drug: NXY-059

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3200

Completion Date

September 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Israel, Korea, Republic of, Mexico, New Zealand, Philippines, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00061022

Responsible Party

Study ID Numbers ^ICMJE

SA-NXY-0007, 007, SAINT 2

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca NXY-059 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP