Acute Ischemic Stroke Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke
To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke
The limited therapeutic time window for neuroprotection has prevented all clinical trials using NMDA receptor antagonists in subjects with ischemic stroke from showing efficacy. In animal models of ischemic stroke, antioxidants showed a longer neuroprotective time window than NMDA receptor antagonists, and also showed therapeutic potential in clinical trials in subjects with ischemic stroke. Sophadil showed good neuroprotective effects against NMDA and free-radical mediated cell death, NR2B-selectivity, moderate NMDA receptor antagonism, and effective cellular osmotic antioxidant activity even at nanoscale molarity. Non-clinical and phase I human clinical studies have shown that Sofadil is helpful in treating ischemic stroke subjects with better efficacy and therapeutic time windows. So we designed the clinical trial to evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke ;
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