title: Efficacy and safety of lacosamide as first add-on or later adjunctive treatment for uncontrolled partial-onset seizures: A multicentre open-label trial.
abstract: To evaluate the efficacy and safety of lacosamide administered as either first add-on or later add-on antiepileptic drug (AED) therapy for patients with uncontrolled partial-onset seizures (POS).
  
  
  
  In this open-label, multicentre trial, patients with POS initiated oral lacosamide (titrated to 400 mg/day) either as add-on to first AED monotherapy, or as later add-on to 1-3 concomitant AEDs after ≥ 2 previous AEDs. The primary efficacy variable was the proportion of patients achieving seizure freedom for the first 12 weeks of the 24-week Maintenance Phase.
  
  
  
  456 patients received ≥ 1 dose of lacosamide (96 as first add-on, 360 as later add-on). In the first add-on cohort, 27/72 (37.5%) patients completed 12 weeks treatment and remained seizure-free; 18/68 (26.5%) remained seizure-free after 24 weeks. 64/91 (70.3%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. This was accompanied by a mean 7.1 ± 16.00 point improvement from Baseline in the Quality of Life Inventory in Epilepsy (QOLIE-31-P) total score for 24-week completers, with improvement reported in all subscales. Most common treatment-emergent adverse events (TEAEs) were dizziness (31.3%) and headache (13.5%). In the later add-on cohort, 39/261 (14.9%) and 29/249 (11.6%) patients remained seizure-free after completing 12 and 24 weeks' treatment, respectively. 178/353 (50.4%) patients achieved ≥ 50% reduction in seizure frequency during maintenance treatment. Mean change in QOLIE-31-P total score was 4.8 ± 14.74 points among 24-week completers. Common TEAEs were dizziness (33.6%), somnolence (15.0%) and headache (11.4%).
  
  
  
  Lacosamide initiated as first add-on treatment was efficacious and well tolerated in patients with uncontrolled POS.
authors.affiliation: Broadlawns Medical Center, 1801 Hickman Road, Des Moines, IA 50314, USA. Electronic address: wwaldman@broadlawns.org.
authors.forename: Wendy Waldman
authors.initials: WW
authors.lastname: Zadeh
authors.affiliation: Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Avda. Sant Antoni Maria Claret 167, 08025 Barcelona, Spain. Electronic address: aescartin@santpau.cat.
authors.forename: Antonio
authors.initials: A
authors.lastname: Escartin
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Bill.Byrnes@ucb.com.
authors.forename: William
authors.initials: W
authors.lastname: Byrnes
authors.affiliation: UCB Pharma, Alfred-Nobel-Straße 10, 40789 Monheim am Rhein, Germany. Electronic address: Frank.Tennigkeit@ucb.com.
authors.forename: Frank
authors.initials: F
authors.lastname: Tennigkeit
authors.affiliation: UCB Pharma, 208 Bath Road, Slough SL1 3WE, UK. Electronic address: simon.borghs@ucb.com.
authors.forename: Simon
authors.initials: S
authors.lastname: Borghs
authors.affiliation: UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Ting.Li@ucb.com.
authors.forename: Ting
authors.initials: T
authors.lastname: Li
authors.affiliation: UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Peter.Dedeken@ucb.com.
authors.forename: Peter
authors.initials: P
authors.lastname: Dedeken
authors.affiliation: UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Marc.DeBacker@ucb.com.
authors.forename: Marc
authors.initials: M
authors.lastname: De Backer
mesh_terms: D000081:Acetamides / Q000009:adverse effects* / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012640:Seizures / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide
keywords: Focal epilepsy; Lacosamide; Quality of life; Seizure freedom