Phase IV Study Evaluating Safety and Effectiveness of Sovateltide with Standard Treatment in Adults With Acute Cerebral Ischemic Stroke

What this Trial Is About

Researchers are evaluating the safety and effectiveness of sovateltide also known as PMZ-1620 or IRL-1620 as a potential treatment for acute cerebral ischemic stroke. This phase IV, multicenter, randomized, double-blind study focuses on adults aged 18 to 78 who have experienced an ischemic stroke confirmed by imaging. Sovateltide is being studied because it may activate brain stem cells, promote new neuron and blood vessel growth, prevent cell death, and improve blood flow after stroke, all of which could help brain repair and recovery. The study involves 160 patients split into two groups. One group receives three intravenous doses of sovateltide on days 1, 3, and 6, alongside standard stroke treatment. Each dose is 0.3 micrograms per kilogram of body weight, given over one minute with about three hours between doses, totaling 0.9 micrograms per kilogram daily on those days. The other group receives an equal volume of normal saline on the same schedule plus standard treatment. Patients are monitored closely during the study period for safety and treatment effects. Participants will be followed for three months with three study visits during this time. Researchers will assess stroke severity and recovery using scales like the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index. Safety is tracked by recording adverse events and lab tests, vital signs, and physical exams. The main outcome is the proportion of patients experiencing adverse events within 90 days. The study also evaluates changes in stroke-related scores, quality of life, risk of stroke recurrence, and mortality.

Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke