{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:22:36Z","timestamp":1788870156862,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2014,6,10]],"date-time":"2014-06-10T00:00:00Z","timestamp":1402358400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"UCB Pharma"},{"name":"Marinus"},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100013327","name":"Lundbeck","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100013327","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100009654","name":"Sepracor","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009654","id-type":"DOI","asserted-by":"crossref"}]},{"name":"SK Life Science"},{"DOI":"10.13039\/100015235","name":"Supernus Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015235","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Vertex"},{"name":"Neurotherapeutics Pharma"},{"name":"Velacor"},{"DOI":"10.13039\/100009655","name":"Sunovion","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009655","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Upsher-Smith"},{"name":"Acorda"},{"name":"Eisai Medical Research"},{"name":"GlaxoSmithK"},{"name":"Impax"},{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Mapp Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2014,7]]},"abstract":"Summary<\/jats:title>\n \n Objective<\/jats:title>\n To evaluate the efficacy and safety of conversion to lacosamide 400\u00a0mg\/day monotherapy in adults with focal epilepsy.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This historical\u2010controlled, double\u2010blind study (\n NCT<\/jats:styled-content>\n 00520741) enrolled patients aged 16\u201370\u00a0years on stable doses of 1\u20132 antiepileptic drugs (\n AED<\/jats:styled-content>\n s) and experiencing 2\u201340 partial\u2010onset seizures per 28\u00a0days during the 8\u2010week prospective Baseline. Patients were randomized to lacosamide 400 or 300\u00a0mg\/day (3:1 ratio), starting at 200\u00a0mg\/day and titrated over 3\u00a0weeks to randomized dose. Patients then withdrew background\n AED<\/jats:styled-content>\n s over 6\u00a0weeks and entered a 10\u2010week Monotherapy Phase. The primary assessment was the Kaplan\u2010Meier\u2013predicted percentage of patients on 400\u00a0mg\/day in the full analysis set (\n FAS<\/jats:styled-content>\n ) meeting \u22651 predefined seizure\u2010related exit criterion by day 112, compared with the historical\u2010control threshold (65.3%).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Four hundred twenty\u2010five patients were enrolled and were eligible for safety analyses (400\u00a0mg\/day, n\u00a0=\u00a0319; 300\u00a0mg\/day, n\u00a0=\u00a0106). A total of 271 (63.8%) of 425 patients completed the Lacosamide Maintenance Phase (combined\n AED<\/jats:styled-content>\n Withdrawal and Monotherapy Phases). Among 284 patients in the 400\u00a0mg\/day group in the\n FAS<\/jats:styled-content>\n , 82 (28.9%) met \u22651 exit criterion; the Kaplan\u2010Meier\u2013predicted exit percentage at day 112 for 400\u00a0mg\/day (30.0%; 95% confidence interval [\n CI]<\/jats:styled-content>\n 24.6\u201335.5%) was lower than the historical control. When exit events, withdrawal due to treatment\u2010emergent adverse events (\n TEAE<\/jats:styled-content>\n s), and withdrawal due to lack of efficacy were summed (n\u00a0=\u00a090), the predicted exit percentage (32.3%; 95%\n CI<\/jats:styled-content>\n 26.8\u201337.8%) was also lower than the historical control. Most patients receiving 400\u00a0mg\/day reported some improvement on the Clinical Global Impression of Change (75.4%) and Patient Global Impression of Change (74.3%). Overall, the most common (>10%)\n TEAE<\/jats:styled-content>\n s were dizziness (24.0%), headache (14.4%), nausea (13.4%), convulsion (11.5%), somnolence (10.4%), and fatigue (10.1%); most (74.1%) were mild\u2010to\u2010moderate in intensity. Seventy\u2010two patients (16.9%) discontinued due to\n TEAE<\/jats:styled-content>\n s. Seventeen patients (4%, all receiving 400\u00a0mg\/day) experienced serious\n AE<\/jats:styled-content>\n s.\n <\/jats:p>\n <\/jats:sec>\n \n Significance<\/jats:title>\n Lacosamide 400\u00a0mg\/day monotherapy was effective, with a favorable safety profile in patients with focal epilepsy.<\/jats:p>\n \n A PowerPoint slide summarizing this article is available for download in the Supporting Information section\n here<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/epi.12681","type":"journal-article","created":{"date-parts":[[2014,6,10]],"date-time":"2014-06-10T11:10:48Z","timestamp":1402398648000},"page":"1088-1098","source":"Crossref","is-referenced-by-count":80,"title":["Conversion to lacosamide monotherapy in the treatment of focal epilepsy: Results from a historical\u2010controlled, multicenter, double\u2010blind study"],"prefix":"10.1111","volume":"55","author":[{"given":"Robert T.","family":"Wechsler","sequence":"first","affiliation":[{"name":"Consultants in Epilepsy and Neurology PLLC Boise Idaho U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Li","sequence":"additional","affiliation":[{"name":"Medsol Clinical Research Center Port Charlotte Florida U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"French","sequence":"additional","affiliation":[{"name":"NYU Comprehensive Epilepsy Center New York New York U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terence J.","family":"O'Brien","sequence":"additional","affiliation":[{"name":"The Departments of Medicine and Neurology The Royal Melbourne Hospital The University of Melbourne Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O'Neill","family":"D'Cruz","sequence":"additional","affiliation":[{"name":"UCB Pharma Raleigh North Carolina 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