Synopsis

Tolperisone, a skeletal muscle relaxant (SMR) being developed in the United States, does not appear to exhibit the central nervous system adverse events (AEs) such as somnolence typically seen with SMRs. This study evaluated the effects of tolperisone versus cyclobenzaprine and placebo on driving performance, somnolence, cognitive function, and safety. The effects of tolperisone on driving performance were comparable to those of placebo but contrasted with the significant declines in performance in subjects treated with cyclobenzaprine. Similarly, subjects treated with tolperisone demonstrated cognitive function, levels of self-reported sleepiness, and rates of somnolence AEs comparable to those of placebo.

Disclosures

This study was supported by Neurana Pharmaceuticals, Inc.
Gary Kay is an owner of Cognitive Research Corporation, which served as a contract research organization for this study, and is the author, publisher, and owner of CogScreen-AE, the cognitive test battery used in this study for assessment of treatment effects on cognitive functioning.
Sanam Ara Vaughn is an employee of Neurana Pharmaceuticals.
Nathan Cashdollar reports other disclosures from Cambridge Cognition Ltd outside the submitted work.
Randall Kaye is an employee of Neurana Pharmaceuticals.

Dr. Randall Kaye MD

Neurana Pharmaceuticals Inc

Appearances