NCT00119626

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

1.7 years

First QC Date

July 6, 2005

Last Update Submit

November 10, 2010

Conditions

Cerebral StrokeIschemic Attack, Transient

Keywords

Stroke, AcuteCerebrovascular Stroke

Outcome Measures

Primary Outcomes (1)

  • Global disability on modified Rankin scale at 90 days.

Secondary Outcomes (1)

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

Interventions

NXY-059DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours
  • Full functional independence prior to the present stroke

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Södertälje, Sweden

Location

Research Site

Glasgow, United Kingdom

Location

Related Publications (1)

  • Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):588-600. doi: 10.1056/NEJMoa052980.

    PMID: 16467546RESULT

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

disufenton sodium

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • AstraZeneca NXY-059 Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

June 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

GB(1)SE(1)