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Completed

NCT Number: NCT00061022

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

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.

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Key information

Conditions

Cerebral Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Cataplexy Central Nervous System Diseases Cerebrovascular Disorders Cerebrovascular Stroke Disorders of Excessive Somnolence Dyssomnias Hemorrhage Ischemia Ischemic Attack, Transient Mental Disorders Narcolepsy Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Stroke, Acute Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Boulogne Sur Mer, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NXY-059

Drug

Primary outcomes

  1. Global disability on modified Rankin scale at 90 days.

Secondary outcomes

  1. NIH stroke scale

  2. Barthel Index

  3. Stroke Impact Scale

  4. EQ-5D all at 90 days

  5. Safety outcomes

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
May 21, 2003
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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