title: Lacosamide in patients with temporal lobe epilepsy: An observational multicentric open-label study.
abstract: The aim of this study was to evaluate the efficacy and tolerability of lacosamide (LCM) both as add-on therapy and monotherapy in patients with temporal lobe epilepsy (TLE) based on an observational, prospective, multicenter study.
  
  
  
  We enrolled 100 patients (mean age: 43.4±12.53years, 57 females) with nonlesional TLE and TLE with hippocampal sclerosis (HS) that did not respond to the first drug and who were referred to epilepsy centers of the University of Catanzaro, University of Palermo, IRCSS Neuromed of Pozzilli, and Otto-von-Guericke University of Magdeburg. In this open-label, multicenter trial, patients were initiated on oral LCM as add-on therapy to first AED monotherapy or as a later add-on to two concomitant AEDs. Seizure frequency changes and adverse events were recorded for at least six months after LCM was added.
  
  
  
  Fourteen patients dropped out because of positive MRI findings other than HS. Patients received LCM at 200-400mg/day. Fifty-eight out of these 86 patients with seizures that were previously drug-resistant had reduced seizure frequency after introduction of LCM. Forty-five out of 86 patients were classified as responders (12 were seizure-free, 33 achieved a reduction >50%). Interestingly, five patients out of 86 achieved seizure freedom for at least one year and progressively switched to monotherapy with LCM, and all five remained seizure-free at follow-up (6-48months).
  
  
  
  Our results may suggest that LCM at doses of 200 to 400mg/day reduces seizure frequency in adults with TLE regardless of the presence of HS, and that it may be considered as a first add-on treatment for patients with pharmacoresistant TLE.
authors.affiliation: Institute of Neurology, University "Magna Graecia", Catanzaro, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Borzì
authors.affiliation: IRCSS Neuromed, Pozzilli, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Di Gennaro
authors.affiliation: Department of Neurology, Otto-von-Guericke University, Magdeburg, Germany.
authors.forename: Friedhelm C
authors.initials: FC
authors.lastname: Schmitt
authors.affiliation: IRCSS Neuromed, Pozzilli, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: D'Aniello
authors.affiliation: Institute of Neurology, University "Magna Graecia", Catanzaro, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Mumoli
authors.affiliation: Experimental Biomedicine and Clinical Neuroscience Department (BioNeC), University of Palermo, Palermo, Italy.
authors.forename: Lelila
authors.initials: L
authors.lastname: Zummo
authors.affiliation: Experimental Biomedicine and Clinical Neuroscience Department (BioNeC), University of Palermo, Palermo, Italy.
authors.forename: Ornella
authors.initials: O
authors.lastname: Daniele
authors.affiliation: Department of Health Sciences, School of Specialization in Pharmacology, University "Magna Graecia", Catanzaro, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Russo
authors.affiliation: Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Institute of Molecular Bioimaging and Physiology of the National Research Council (IBFM-CNR), Catanzaro, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gambardella
authors.affiliation: Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Institute of Molecular Bioimaging and Physiology of the National Research Council (IBFM-CNR), Catanzaro, Italy. Electronic address: labate@unicz.it.
authors.forename: Angelo
authors.initials: A
authors.lastname: Labate
mesh_terms: D000081:Acetamides / Q000008:administration & dosage*; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D004833:Epilepsy, Temporal Lobe / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000078334:Lacosamide; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Lacosamide; Open-label study; TLE