Phase II Study to Assess Safety and Effectiveness of LT3001 Infusion Treatment in Adults with Acute Ischemic Stroke

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LT3001 for treating acute ischemic stroke. This phase II multicenter study compares LT3001 at high and low doses to a placebo, aiming to understand how well LT3001 works and how safe it is for patients who have suffered this type of stroke. The study is led by Shanghai Pharmaceuticals Holding Co., Ltd and involves participants aged 18 to 80 years. Participants will receive LT3001 or placebo through intravenous infusion. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment must begin within 24 hours after stroke onset. The trial evaluates multiple outcomes, including stroke severity and daily living abilities at various time points up to 90 days after the first dose. During the study, participants will undergo neurological assessments using scales like the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index at several days after treatment. The main safety measure is the occurrence of adverse events, monitored for about two years. Participants will be closely followed to assess recovery progress and any side effects over time.

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke