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:
NCT00119626
First received: July 6, 2005
Last updated: November 10, 2010
Last verified: November 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Primary Completion Date: February 2005 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00119626     History of Changes
Other Study ID Numbers: SA-NXY-0006, 0006, SAINT I
Study First Received: July 6, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Stroke, Acute
Cerebrovascular Stroke

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 July 24, 2014