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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00061022




Registration number
NCT00061022
Ethics application status
Date submitted
20/05/2003
Date registered
21/05/2003
Date last updated
15/11/2010

Titles & IDs
Public title
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Scientific 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
Secondary ID [1] 0 0
007
Secondary ID [2] 0 0
SA-NXY-0007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Stroke 0 0
Stroke, Acute 0 0
Cerebrovascular Stroke 0 0
Ischemic Attack, Transient 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Global disability on modified Rankin scale at 90 days.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
NIH stroke scale
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Barthel Index
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Stroke Impact Scale
Timepoint [3] 0 0
Secondary outcome [4] 0 0
EQ-5D all at 90 days
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Safety outcomes
Timepoint [5] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Gosford
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - New Lambton
Recruitment hospital [7] 0 0
Research Site - Parkville
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- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Gosford
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- Heidelberg
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- New Lambton
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- Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00061022
Trial related presentations / publications
Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca NXY-059 Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00061022