PMID- 27517350 OWN - NLM STAT- MEDLINE DCOM- 20170901 LR - 20181202 IS - 1525-5069 (Electronic) IS - 1525-5050 (Linking) VI - 62 DP - 2016 Sep TI - Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. PG - 267-75 LID - S1525-5050(16)30239-6 [pii] LID - 10.1016/j.yebeh.2016.07.007 [doi] AB - 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 (150mg, b.i.d.) and CBZ-IR (200mg, 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 (4weeks 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: 34.4years [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. CI - Copyright (c) 2016 Elsevier Inc. All rights reserved. FAU - Meador, Kimford J AU - Meador KJ AD - Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu. FAU - Loring, David W AU - Loring DW AD - Department of Neurology, Emory University, Atlanta, GA, USA; Department of Pediatrics, Emory University, Atlanta, GA, USA. Electronic address: dloring@emory.edu. FAU - Boyd, Alan AU - Boyd A AD - CNS Vital Signs, Morrisville, NC, USA. Electronic address: aboyd@cnsvs.com. FAU - Echauz, Javier AU - Echauz J AD - JE Research, Inc., Alpharetta, GA, USA. Electronic address: echauz@ieee.org. FAU - LaRoche, Suzette AU - LaRoche S AD - Department of Neurology, Emory University, Atlanta, GA, USA. Electronic address: Suzette.LaRoche@msj.org. FAU - Velez-Ruiz, Naymee AU - Velez-Ruiz N AD - Department of Neurology, Emory University, Atlanta, GA, USA. Electronic address: nxv146@med.miami.edu. FAU - Korb, Pearce AU - Korb P AD - Department of Neurology, University of Colorado, Denver, CO, USA. Electronic address: pearce.korb@ucdenver.edu. FAU - Byrnes, William AU - Byrnes W AD - UCB Pharma, Raleigh, NC, USA. Electronic address: Bill.Byrnes@ucb.com. FAU - Dilley, Deanne AU - Dilley D AD - UCB Pharma, Raleigh, NC, USA. Electronic address: Deanne.Dilley@ucb.com. FAU - Borghs, Simon AU - Borghs S AD - UCB Pharma, Slough, UK. Electronic address: Simon.Borghs@ucb.com. FAU - De Backer, Marc AU - De Backer M AD - UCB Pharma, Brussels, Belgium. Electronic address: Marc.DeBacker@ucb.com. FAU - Story, Tyler AU - Story T AD - UCB Pharma, Atlanta, GA, USA. Electronic address: TylerJStory@gmail.com. FAU - Dedeken, Peter AU - Dedeken P AD - UCB Pharma, Brussels, Belgium. Electronic address: Peter.Dedeken@ucb.com. FAU - Webster, Elizabeth AU - Webster E AD - UCB Pharma, Raleigh, NC, USA. Electronic address: Elizabeth.Webster@ucb.com. LA - eng SI - ClinicalTrials.gov/NCT01530022 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20160810 PL - United States TA - Epilepsy Behav JT - Epilepsy & behavior : E&B JID - 100892858 RN - 0 (Acetamides) RN - 0 (Anticonvulsants) RN - 33CM23913M (Carbamazepine) RN - 563KS2PQY5 (Lacosamide) SB - IM MH - Acetamides/*pharmacology MH - Adolescent MH - Adult MH - Anticonvulsants/*pharmacology MH - Brain/*drug effects MH - Carbamazepine/*pharmacology MH - Cognition/*drug effects MH - Cross-Over Studies MH - Double-Blind Method MH - Electroencephalography MH - Female MH - Humans MH - Lacosamide MH - Male MH - Middle Aged MH - Neuropsychological Tests MH - Young Adult OTO - NOTNLM OT - Carbamazepine OT - Cognition OT - EEG OT - Lacosamide OT - Neuropsychology EDAT- 2016/08/16 06:00 MHDA- 2017/09/02 06:00 CRDT- 2016/08/13 06:00 PHST- 2016/05/19 00:00 [received] PHST- 2016/07/01 00:00 [revised] PHST- 2016/07/02 00:00 [accepted] PHST- 2016/08/13 06:00 [entrez] PHST- 2016/08/16 06:00 [pubmed] PHST- 2017/09/02 06:00 [medline] AID - S1525-5050(16)30239-6 [pii] AID - 10.1016/j.yebeh.2016.07.007 [doi] PST - ppublish SO - Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10.