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Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
This study has been completed.
First Received: May 20, 2003   Last Updated: March 18, 2009   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 II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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
  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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00061022

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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 National Clinical Trials Identifier (NCT ID):
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.

Study ID Numbers: SA-NXY-0007, 007, SAINT 2
Study First Received: May 20, 2003
Last Updated: March 18, 2009
ClinicalTrials.gov Identifier: NCT00061022     History of Changes
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
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 November 22, 2009



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