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Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

2014-08-27 03:22:27 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Acute Ischemic Stroke

Intervention

DP-b99, Placebo

Location

MetroHealth Medical Center
Cleveland
Ohio
United States
18104

Status

Recruiting

Source

D-Pharm Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:22:27-0400

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