Results of Open-Label, Randomized, Controlled, Parallel-Group Clinical Trial on the Efficacy and Tolerability of Neurocitin in Patients with Acute Ischemic Stroke
The article presents data from a study evaluating the comparative efficacy and tolerability of Neurocitin, solution for infusions, manufactured by «Yuria-Farm» Ltd. and Ceraxon, solution for injections, manufactured by «Ferrer Internacional S.A.» in patients with acute ischemic stroke. The objective of this work — the evaluation of therapeutic equivalence of the drugs Neurocitin and Ceraxon. Materials and methods. The clinical study included 108 patients with acute ischemic stroke, who, based on the method of simple randomization in the ratio 1: 1, were divided in the study (n = 54) and control (n = 54) groups. Patients of the study group received Neurocitin, solution for infusions, patients from the control group — reference product Ceraxon, solution for injections. The course of treatment was 3 weeks, followed by a 3-week observation. Treatment efficacy was determined by the main variable — reduction in the score on the NIHSS, the severity of stroke scale, compared with baseline. Safety of the drug was evaluated based on monitoring the patient’s condition, the incidence and nature of adverse events, the data of laboratory examination, assessment of the subjective condition of the patient. Results. The study shows that Neurocitin is highly effective and on its properties is therapeutically equivalent to foreign analogue — the drug Ceraxon. During the treatment, no severe or unexpected adverse events were detected, laboratory parameters did not undergo negative changes that allowed to consider the tolerability in both groups as good one. Conclusions. Based on these findings, Neurocitin, solution for infusions, manufactured by «Yuria-Pharm» Ltd. can be recommended as an effective and safe drug in patients with acute ischemic stroke.
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