Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine |
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| Institution: | 1. Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA;2. Department of Neurology, Emory University, Atlanta, GA, USA;3. Department of Pediatrics, Emory University, Atlanta, GA, USA;4. CNS Vital Signs, Morrisville, NC, USA;5. JE Research, Inc., Alpharetta, GA, USA;6. Department of Neurology, University of Colorado, Denver, CO, USA;7. UCB Pharma, Raleigh, NC, USA;8. UCB Pharma, Slough, UK;9. UCB Pharma, Brussels, Belgium;10. UCB Pharma, Atlanta, GA, USA;1. Adiyaman University Training and Research Hospital, Neurology, Adiyaman, Turkey;2. Adiyaman University Training and Research Hospital, Radiology, Adiyaman, Turkey;3. Tekirdag Goverment Hospital, Child Psychiatry, Tekirdag, Turkey;4. Adiyaman University Training and Research Hospital, Physical Medicine and Rehabilitation, Adiyaman, Turkey;5. Adiyaman University Training and Research Hospital, Psychology, Adiyaman, Turkey;1. Epilepsy-Center Berlin-Brandenburg, Berlin, Germany;2. Department of Neurology, Charité - Universitätsmedizin, Berlin, Germany;1. Medical College of Wisconsin, Department of Neurology, United States of America;2. Rosalind Franklin University of Medicine and Science, United States of America;1. Department of Epileptology, University of Bonn, Sigmund Freud Str. 26, Bonn 53015, Germany;2. Krankenhaus Mara, Epilepsiezentrum Bethel, Bielfeld, Germany;3. UCB Pharma, Raleigh, NC, USA;4. UCB Pharma, Brussels, Belgium;5. UCB Pharma, Monheim-am-Rhein, Germany |
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| 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. |
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