@article{908ff656e47742b2ae338fd004043a72,
title = "Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine",
abstract = "Differential effectiveness of antiepileptic drugs (AEDs) is more commonly determined by tolerability than efficacy. Cognitive effects of AEDs can adversely affect tolerability and quality of life. This study evaluated cognitive and EEG effects of lacosamide (LCM) compared with carbamazepine immediate-release (CBZ-IR). A randomized, double-blind, double-dummy, two-period crossover, fixed-dose study in healthy subjects compared neuropsychological and EEG effects of LCM (150 mg, b.i.d.) and CBZ-IR (200 mg, t.i.d.). Testing was conducted at screening, predrug baseline, the end of each treatment period (3-week titration; 3-week maintenance), and the end of each washout period (4 weeks after treatment). A composite Z-score was derived for the primary outcome variable (computerized cognitive tests and traditional neuropsychological measures) and separately for the EEG measures. Other variables included individual computer, neuropsychological, and EEG scores and adverse events (AEs). Subjects included 60 healthy adults (57% female; mean age: 34.4 years [SD: 10.5]); 44 completed both treatments; 41 were per protocol subjects. Carbamazepine immediate-release had worse scores compared with LCM for the primary composite neuropsychological outcome (mean difference = 0.33 [SD: 1.36], p = 0.011) and for the composite EEG score (mean difference = 0.92 [SD: 1.77], p = 0.003). Secondary analyses across the individual variables revealed that CBZ-IR was statistically worse than LCM on 36% (4/11) of the neuropsychological tests (computerized and noncomputerized) and 0% of the four EEG measures; none favored CBZ-IR. Drug-related AEs occurred more with CBZ-IR (49%) than LCM (22%). Lacosamide had fewer untoward neuropsychological and EEG effects and fewer AEs and AE-related discontinuations than CBZ-IR in healthy subjects. Lacosamide exhibits a favorable cognitive profile.",
keywords = "Carbamazepine, Cognition, EEG, Lacosamide, Neuropsychology",
author = "Meador, {Kimford J.} and Loring, {David W.} and Alan Boyd and Javier Echauz and Suzette LaRoche and Naymee Velez-Ruiz and Pearce Korb and William Byrnes and Deanne Dilley and Simon Borghs and {De Backer}, Marc and Tyler Story and Peter Dedeken and Elizabeth Webster",
note = "Funding Information: This study was sponsored by UCB Pharma . The authors thank the subjects for their participation in this study. The authors acknowledge Jesse Fishman, Pharm.D. of UCB Pharma (Atlanta, GA), for publication coordination and Lynne Isbell, Ph.D., CMPP of Evidence Scientific Solutions (Philadelphia, PA), for editorial assistance (verifying data accuracy, creating figures, formatting and editing, collating author comments, and coordinating the review process), which was funded by UCB Pharma. Funding Information: Dr. Meador has received research support from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, UCB Pharma, and Sunovion Pharmaceuticals and travel support from UCB Pharma. The Epilepsy Study Consortium pays Dr. Meador's university for his research consultant time related to Eisai, GW Pharmaceuticals, NeuroPace, Novartis, Supernus, Upsher-Smith Laboratories, UCB Pharma, and Vivus Pharmaceuticals. Dr. Loring has received support from the National Institutes of Health and the Patient-Centered Outcomes Research Institute and compensation for consulting services for NeuroPace and Supernus and is an associate editor for Epilepsia. Mr. Boyd is an employee of CNS Vital Signs and received support from UCB Pharma for this study. Dr. Echauz is president of JE Research, Inc. and received support from UCB Pharma. Dr. Laroche received research support from UCB Pharma and royalties from Demos Publishing. Drs. Korb and Velez-Ruiz have no disclosures to report. Dr. Byrnes, Ms. Dilley, Mr. Borghs, Dr. De Backer, Dr. Dedeken, and Dr. Webster are employees of UCB Pharma. Dr. De Backer, Ms. Dilley, and Dr. Webster receive UCB stock and stock options. Dr. Dedeken has received UCB stock and stock options. Dr. Story was an employee of UCB Pharma at the time of this study. Publisher Copyright: {\textcopyright} 2016 Elsevier Inc.",
year = "2016",
month = sep,
day = "1",
doi = "10.1016/j.yebeh.2016.07.007",
language = "English (US)",
volume = "62",
pages = "267--275",
journal = "Epilepsy and Behavior",
issn = "1525-5050",
publisher = "Academic Press Inc.",
}