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The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 within 1-9 hours of acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.
This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d for 4 consecutive days, in patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or neglect (specifically, at least 1 point on NIHSS items 3, 9 or 11). Alternatively, patients without at least 1 point on NIHSS items 3, 9 or 11 may be enrolled if routine diffusion-weighted magnetic resonance imaging (DW MRI) or computed tomography perfusion scan indicates that the acute stroke involves the cerebral cortex, and as long as the overall acute neurological deficit is within the range of 10-16 NIHSS points. Clinical trial material (CTM) will be administered within 1 to 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. After the initial hospitalization (which should be at least 4 days) follow up visits will take place on study days 30 and 90.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Acute Ischemic Stroke
MetroHealth Medical Center
Published on BioPortfolio: 2014-08-27T03:22:27-0400
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