Study of JX10 Versus Placebo to Improve Recovery After Acute Ischemic Stroke Occurring 4.5 to 24 Hours Before Treatment A Phase 23 Randomized, Double-Blind Study Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of JX10 compared to a placebo in adults aged 18 to 90 who have experienced an acute ischemic stroke and present for care between 4.5 to 24 hours after stroke onset. The study aims to determine if JX10 improves functional outcomes measured by the modified Rankin Scale and to assess the risk of symptomatic intracranial hemorrhage. This is a multicenter, double-blind, randomized, placebo-controlled study sponsored by Corxel Pharmaceuticals, conducted in phases 2 and 3. Participants in Part 1 are randomly assigned to receive either JX10 at doses of 1 mgkg or 3 mgkg, or a placebo. In Part 2, participants receive the optimal JX10 dose selected from Part 1 or a placebo. The treatment involves intravenous administration of a thrombolytic agent, JX10, designed to improve blood flow by dissolving clots. The study uses a quadruple masking design to ensure unbiased results. Throughout the study, participants will be monitored and assessed for functional recovery using the modified Rankin Scale at 90 days, with safety evaluations including the incidence of symptomatic intracranial hemorrhage within 36 hours post-treatment. Additional assessments include adverse events, serious adverse events, and major bleeding occurrences within 24 hours and up to 14 days after treatment. Total participation spans at least 90 days, during which clinical and radiographic evaluations will be conducted to track progress and safety.

Optimizing Reperfusion to Improve Outcomes and Neurologic Function