CNS Network, a clinical research center in Southern California, has been chosen by Cognitive Research to conduct a driving simulation cross-over study of the sedative effects of a muscle relaxant as compared to a different muscle relaxant and a placebo.
FDA draft guidance indicates that driving studies will be required for a broader range of compounds. The guidance indicates that a dedicated driving study will be necessary when “accumulating data suggest a potential for driving impairment.” The guidance also specifies that driving simulators are suitable for conducting these studies.
“Our company is well qualified to conduct this study,” said CNS Network CEO David P. Walling, Ph.D. “Our Long Beach facility has four state-of-the-art CRCDS MiniSim PC-based driving simulators dedicated to clinical trials.”
Developed by the University of Iowa, the CRCDS MiniSim driving simulator has been fully validated for use in clinical trials. The CRCDS MiniSim has proven sensitivity to alcohol, depressants, and stimulants, and is designed to study the effects of driving abilities in both normal and patient populations.