A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

What this Trial Is About

Researchers are investigating sovateltide, a drug that targets ETB receptors, as a potential treatment for acute cerebral ischemic stroke, a serious condition caused by a blocked blood vessel in the brain. This type of stroke leads to brain tissue damage due to lack of oxygen and is more common than hemorrhagic stroke. Previous studies in animals and early human trials have shown sovateltide may help protect and repair brain cells, encouraging further research in a phase III clinical trial across multiple countries. The study compares sovateltide with a placebo normal saline alongside standard care for stroke patients. Participants receive three intravenous bolus doses of sovateltide or placebo over one minute each, spaced every 3 hours on day 1, with repeated dosing on days 3 and 6. The treatment starts within 24 hours after stroke symptoms begin. This randomized, double-blind trial aims to assess safety and how well sovateltide improves recovery compared to placebo. Participants will be closely monitored over 90 days, with evaluations including neurological function using scales like the modified Rankin Scale, National Institute of Health Stroke Scale, and Barthel Index. Quality of life and cognitive function will also be assessed at multiple points. Researchers will track any adverse events, recurrent strokes, and mortality. The study requires patients to be available for full treatment and follow-up to measure sovateltides effects comprehensively.

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