Study of Cerebrolysin for Treating Long-Term Disorders of Consciousness After Hemorrhagic Stroke

What this Trial Is About

Researchers are evaluating the effects of Cerebrolysin on patients with prolonged disorders of consciousness caused by hemorrhagic stroke. This pilot phase 4 study focuses on patients who have been in a vegetative or minimally conscious state for more than four weeks following their stroke. The study aims to assess the safety and efficacy of Cerebrolysin treatment compared to a placebo control group. Participants receive either 30 ml of Cerebrolysin combined with 70 ml of normal saline or 100 ml of normal saline alone. Both treatments are administered intravenously once daily from days 4 to 17 after randomization. The study uses a randomized and quadruple-blinded design to compare these two groups. During the study, participants will be evaluated using the Coma Recovery Scale-Revised and Positron Emission Tomography PET scans at two time points 2 days and 17 days after randomization. The research team will monitor changes in consciousness levels and brain metabolism. The total study duration includes the treatment period and follow-up assessments up to day 17.

Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness