Pilot Study to Evaluate the Safety and Effectiveness of Mexidol Solution and Mexidol FORTE Tablets in Treating Hyperacute and Acute Ischemic Stroke

What this Trial Is About

Researchers are evaluating the effects and mechanisms of Mexidol both injectable solution and oral tablets in patients experiencing the hyperacute and acute stages of ischemic stroke. This pilot, randomized, multicenter, open-label study aims to understand how Mexidol impacts clinical outcomes and brain imaging results compared to Glycine tablets, with 100 stroke patients and 20 healthy volunteers enrolled. The study focuses on safety and efficacy during early stroke treatment phases. The trial includes two patient groups one receives Mexidol solution intravenously twice daily for 10 days followed by Mexidol FORTE tablets three times daily for 60 days, alongside standard stroke care. The other group receives Glycine sublingual tablets once daily for 5 days with standard care. Healthy volunteers do not receive treatment but provide baseline biomarker data. Treatments are given according to current clinical guidelines. Participants undergo multiple evaluations including brain imaging MRI and CT, blood tests for biomarkers and coagulation, and clinical assessments like the National Institutes of Health Stroke Scale and modified Rankin Scale. Assessments occur at baseline, day 11, and follow-ups up to day 90. Safety and tolerability are monitored throughout the study, which spans from initial treatment to three months post-treatment.

Mexidol® Safety and Efficacy in Treatment of Hyperacute and Acute Ischemic Stroke