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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00061022
First received: May 20, 2003
Last updated: November 10, 2010
Last verified: November 2010
History of Changes
  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 3

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:

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):

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 June 18, 2013