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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119626

Enrollment

1700

Registered

2005-07-14

Start date

2003-06-30

Completion date

2005-02-28

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke, Ischemic Attack, Transient

Keywords

Stroke, Acute, Cerebrovascular Stroke

Brief summary

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.

Interventions

DRUGNXY-059

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Global disability on modified Rankin scale at 90 days.	—

Secondary

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

Countries

Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026