Phase II Study of MT200605 for Treating Acute Ischemic Stroke Randomized, Double-Blind, Placebo-Controlled Trial in Adults 18 to 80 Years

What this Trial Is About

Researchers are evaluating MT200605, a drug that acts like brain-derived neurotrophic factor BDNF by protecting brain nerve tissues and supporting energy production in the brains striatum. This study focuses on patients who have had an acute ischemic stroke within 24 hours, aiming to see if MT200605 can help reduce brain injury and improve recovery. The trial is a Phase II exploratory study conducted at 32 centers in China, enrolling 360 patients. Participants will be randomly assigned to receive either a low, medium, or high dose of MT200605 or a placebo. All patients will also receive standard medical care. The study drug or placebo is given twice daily by intravenous infusion for 14 consecutive days. The trial uses a double-blind design, meaning neither participants nor researchers know which treatment is given. During the study, researchers will assess patients using the modified Rankin Scale mRS to measure disability three months after the stroke. They will also evaluate changes in the National Institutes of Health Stroke Scale NIHSS score two weeks after treatment. Safety, brain function, and recovery will be closely monitored throughout the trial, which starts in October 2025 and continues until June 2026.

A Clinical Trial of MT200605 for the Treatment of Acute Ischemic Stroke