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Researchers are studying the effects of Mexidol®, given both as an intravenous solution and as oral tablets, on patients who have recently experienced ischemic stroke. This pilot, randomized, multicenter, open-label study aims to better understand how Mexidol® works during the early and acute phases of stroke and to assess its impact on clinical symptoms and brain imaging outcomes. It also compares Mexidol® treatment to Glycine tablets while monitoring safety and effectiveness in both patients and healthy volunteers. Participants with acute ischemic stroke are randomly assigned to two groups. The first group receives Mexidol® solution intravenously twice daily for 10 days, followed by Mexidol® FORTE 250 mg tablets three times daily for 60 days, alongside standard stroke care. The second group receives Glycine sublingual tablets once daily for 5 days, also with standard care. Healthy volunteers will not receive treatment but will provide baseline biomarker data. The total treatment and observation period lasts up to 70 days for patients. During the study, participants undergo clinical evaluations, laboratory tests, and brain imaging such as CT or MRI scans to assess stroke damage and recovery. Researchers measure outcomes including infarct volume at day 11 and monitor safety throughout the trial. Both patients and healthy volunteers provide informed consent, and adherence to treatment and contraception requirements is tracked. The study includes follow-up assessments to evaluate the effects of the treatments over time.

Age: 18Years - 90YearsAll GendersPhase 4
9 locations