Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Status and phase
Completed
Phase 3
Conditions
Ischemic Attack, Transient
Cerebral Stroke
Treatments
Drug: NXY-059
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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