Cognitive effects of carisbamate in randomized, placebo-controlled, healthy-volunteer, multidose studies

Epilepsy Behav. 2011 Oct;22(2):324-30. doi: 10.1016/j.yebeh.2011.07.006. Epub 2011 Aug 17.

Abstract

Adverse cognitive effects are an important concern for drugs that influence the central nervous system. Carisbamate is a novel drug in development for treatment of seizures and neuropathic pain. Information on its cognitive effects is limited. Three controlled, multiple-dose, crossover studies with treatment durations of 5-9 days were designed to examine the cognitive effects of carisbamate on healthy volunteers. In one study, apparent dose-dependent effects on response, vigilance, and recognition speed were observed (1000 mg and 1500 mg/day). Carisbamate did not differ from placebo for most variables in the other two studies, but increased reaction time and reduced Sternberg memory were seen at higher dosages. Carisbamate did not produce clinically significant adverse effects on cognitive performance at doses <1000 mg/day. Effects were mild to modest at the higher doses tested.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anticonvulsants / adverse effects*
  • Arousal / drug effects
  • Carbamates / adverse effects*
  • Choice Behavior / drug effects
  • Cognition Disorders / chemically induced*
  • Cognition Disorders / diagnosis
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Memory / drug effects
  • Neuropsychological Tests
  • Photic Stimulation
  • Reaction Time / drug effects
  • Time Factors

Substances

  • Anticonvulsants
  • Carbamates
  • S-2-O-carbamoyl-1-o-chlorophenyl-ethanol