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 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.

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Key information

Conditions

Cerebral Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Södertälje, Sweden

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

Treatment and study plan

NXY-059

Drug

Primary outcomes

Global disability on modified Rankin scale at 90 days.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Jul 14, 2005
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.

Published trials that share one or more normalized conditions with this study.

Completed