Acute ischemic stroke.
Conditions
Interventions
Product Code: NXY-059
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: disufenton sodium
CAS Number: 168021-79-2
Current Sponsor code: NXY-059
Concentration unit: % perc
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of written informed consent. Males and females =18 years of age. A clinical diagnosis of acute ischemic stroke with limb weakness as part of the presenting deficit(s). Onset of symptoms within 6 hours of the start of investigational product infusion. Onset time for subjects who awake with symptoms is defined as the last time the subject was awake without symptoms of stroke. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence from neuroimaging studying (CT or MRI scan) or other pre-randomization investigations of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke (onset within 6 hours) likely to cause the present symptoms. Unnconsciousness Severe concurrent illness with life expectancy less than 6 months. Known severe renal disorder from the subject's history. Subjects with a known calculated creatinine clearance of <30 mL/min should be excluded. Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the investigator), permanently sterilized or, if of childbearing potential must have a negative test for pregnancy obtained before randomization and use appropriate contraception at least 3 weeks before randomization until 7 days after last dose of investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the efficacy of NXY-059 compared to placebo in subjects with acute ischemic stroke.;Secondary Objective: To explore the efficacy of NXY-059 compared to placebo on global disability, functional recovery and neurological status. To evaluate the effects of NXY-059 in comparison to placebo on the ability of the subjects to perform activities of daily living (ADLs), mobility and hand function and the domain scores for communication, memory and thinking, emotional function and social participation To evaluate the effects of NXY-059 in comparison to placebo on subjects self-reported health status and health-related quality of life. To evaluate the safety and tolerability of NXY-059 To characterize the pharmacokinetics of NXY-059 To evaluate the effects of NXY-059 compared to placebo on healthcare resource utilization To evaluate the effects of NXY-059 compared to placebo on the place of residence, location of care and work status during the 90 day follow-up period after treatment.;Primary end point(s): Primary efficacy outcome variable of the study is the modified Rankin Scale (mRS) at last rating. The co-primary efficacy outcome variable is total National Institute of Health Stroke Scale (NIHSS) score at the last rating. | — |
Countries
Belgium, Germany, Hungary, Slovakia, Spain, United Kingdom
Outcome results
None listed