Phase 3 Study of Dimephosphon4 for Intravenous Treatment in Adults Aged 35 to 80 With Acute Ischemic Stroke

What this Trial Is About

Researchers are evaluating the efficacy and safety of Dimephosphon4 in patients who have experienced an acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 35 to 80 with verified hemispheric ischemic stroke confirmed by CT or MRI, and neurological scores between 5 and 15 on the NIH Stroke Scale. The trial aims to assess improvements in stroke outcomes using several clinical scales including the Modified Rankin Scale, NIH Stroke Scale, Mini-Mental State Examination, Montreal Cognitive Assessment, and EuroQol 5-Dimensions. Participants are randomly assigned to one of two groups one receiving Dimephosphon4 and the other a placebo. In both groups, from days 1 to 3, the assigned treatment is given as an intravenous infusion three times daily with at least 5 hours between doses. From days 4 to 14, the treatment is administered as an intravenous bolus, also three times daily. The dosing involves 2 grams of the study drug or placebo diluted appropriately for each administration. During the study, participants undergo a screening period lasting up to 48 hours, followed by treatment visits on days 1 through 14, with follow-up assessments up to day 90. Researchers will monitor clinical outcomes and neurological function using established scales at multiple time points, including days 8, 15, 30, and 90. Safety and mortality will also be tracked. The total duration of participation spans from initial screening through the last follow-up visit at day 90.

The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke