Acute intracerebral hemorrhage not caused by trauma or tumor or being secondary to acute ischemic stroke, i.e hemorrhagic transformation.
Conditions
Interventions
Product Name: NXY-059 Concentrate for Solution for Infusion 400 mg/ml Vial 20 ml
Product Code: NXY-059
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: disufenton sodium
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females =18 years of age. A clinical diagnosis of acute stroke with limb weakness as part of the presenting deficit(s) and a neuroimaging scan (CT or MRI) showing an ICH. Onset of symptoms within 6 hours of the planned start of investigational product infusion. Onset time for patients who awake with symptoms is defined as the last time the patient 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 (CT or MRI scan) or other pre?randomization investigations of another cause of the symptom than ICH Unconsciousness (ie, 3 on item 1a. on the NIHSS score). Severe concurrent illness with life expectancy less than 6 months. Known severe renal disorder from the patient's history. Patients with a known calculated creatinine clearance of <30 mL/min using the Jaffe method or <35mL/min using the modified Jaffe or enzymatic method to determine S-Creatinine 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 assess the safety and tolerability of NXY-059 compared to placebo in patients with acute ICH by assessment of mortality (overall and by cause), the incidence of serious adverse events, the incidence of adverse events, change from baseline in the laboratory parameters, change from baseline in vital signs, incidence of abnormalities and change from baseline in ECG parameters, and change from baseline in neuroimaging scans.;Secondary Objective: To explore the efficacy of NXY-059 compared to placebo in patients with acute ICH by evaluating the recovery with respect to global disability, neurological recovery, functional recovery and patient reported disability To investigate the pharmacokinetics of NXY-059 in patients with acute ICH. ;Primary end point(s): Safety Since the assessment of safety and tolerability requires multiple measures, there is no single primary variable selected. Primary outcome variables: - Mortality (overall and by cause) - Incidence of adverse events, serious and non-serious - Change from baseline in laboratory parameters (clinical chemistry, hematology and urine) - Change from baseline in vital signs - Incidence of abnormalities and change from baseline in ECG parameters - Change from baseline in CT/MRI scans. | — |
Countries
Sweden
Outcome results
None listed