{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T08:11:56Z","timestamp":1768291916972,"version":"3.49.0"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,3,18]],"date-time":"2020-03-18T00:00:00Z","timestamp":1584489600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of pregabalin as adjunctive treatment for children (aged 1\u00a0month\u2010&lt;4\u00a0years) with focal onset seizures (FOS) using video\u2010electroencephalography (V\u2010EEG).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, placebo\u2010controlled, international study included V\u2010EEG seizure monitoring (48\u201072\u00a0hours) at baseline and over the last 3\u00a0days of 14\u2010day (5\u2010day dose escalation; 9\u2010day fixed dose) double\u2010blind pregabalin treatment (7 or 14\u00a0mg\/kg\/d in three divided doses). This was followed by a double\u2010blind 1\u2010week taper. The primary efficacy endpoint was log\u2010transformed seizure rate (log<jats:sub>e<\/jats:sub>[24\u2010hour seizure rate\u00a0+\u00a01]) for all FOS recorded during the double\u2010blind V\u2010EEG monitoring, evaluated in subjects who took \u22651 dose of study medication, experienced \u22651 baseline seizure(s), and had a treatment phase V\u2010EEG. Safety and tolerability were assessed by adverse events (AEs), clinical laboratory data, physical\/neurological examinations, vital signs, and electrocardiograms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 175 patients were randomized (mean age = 28.2\u00a0months; 59% male, 69% white, 30% Asian) in a 2:1:2 ratio to pregabalin 7\u00a0or 14\u00a0mg\/kg\/d (n\u00a0=\u00a071 or n\u00a0=\u00a034, respectively), or placebo (n\u00a0=\u00a070). Pregabalin 14\u00a0mg\/kg\/d (n\u00a0=\u00a028) resulted in a statistically significant 35% reduction of log<jats:sub>e<\/jats:sub>(24\u2010hour seizure rate\u00a0+\u00a01) versus placebo (n\u00a0=\u00a053; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.022), an effect that was not observed with pregabalin 7\u00a0mg\/kg\/d (n\u00a0=\u00a059; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.461). The most frequently reported treatment\u2010emergent AEs for pregabalin 7 mg\/kg\/d, 14\u00a0mg\/kg\/d, and placebo, respectively, were somnolence (11.3%, 17.6%, and 5.7%) and upper respiratory tract infection (7.0%, 11.8%, and 11.4%). All AEs were mild to moderate in severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Pregabalin 14\u00a0mg\/kg\/d (but not 7\u00a0mg\/kg\/d) significantly reduced seizure rate in children with FOS, when assessed using V\u2010EEG, compared with placebo. Both pregabalin dosages were generally safe and well tolerated in children 1\u00a0month to &lt;4\u00a0years of age with FOS. Safety and tolerability were consistent with the known profile of pregabalin in older children with epilepsy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.16466","type":"journal-article","created":{"date-parts":[[2020,3,19]],"date-time":"2020-03-19T05:50:28Z","timestamp":1584597028000},"page":"617-626","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Pregabalin adjunctive therapy for focal onset seizures in children 1 month to &lt;4 years of age: A double\u2010blind, placebo\u2010controlled, video\u2010electroencephalographic trial"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7692-7668","authenticated-orcid":false,"given":"Donald","family":"Mann","sequence":"first","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeremias","family":"Antinew","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lloyd","family":"Knapp","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Almas","sequence":"additional","affiliation":[{"name":"Pfizer New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Liu","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Scavone","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruoyong","family":"Yang","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Groton Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Modequillo","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Perpetual Succour Hospital Cebu City Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iryna","family":"Makedonska","sequence":"additional","affiliation":[{"name":"Dnipro City Children\u2019s Clinical Hospital #5 of Dnipro City Council Dnipro Ukraine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marilyn","family":"Ortiz","sequence":"additional","affiliation":[{"name":"Child Neuroscience Division Philippine Children's Medical Center Quezon City Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alla","family":"Kyrychenko","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Dnipro Medical Institute of Conventional and Alternative Medicine Dnipro Ukraine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas","family":"Nordli","sequence":"additional","affiliation":[{"name":"Pediatric Neurology University of Chicago Medicine Chicago Illinois"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Viktor","family":"Farkas","sequence":"additional","affiliation":[{"name":"First Department of Pediatrics Semmelweis University Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark Kristof","family":"Farkas","sequence":"additional","affiliation":[{"name":"First Department of Pediatrics Semmelweis University Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the A0081042 study group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,3,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(97)70027-1"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1999.tb00931.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-013-0048-z"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-015-0281-8"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12830"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/0883073818821035"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2012.04.128"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2006.00656.x"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1997.tb01140.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2010.02522.x"},{"key":"e_1_2_10_12_1","unstructured":"FisherR ShaferP D'SouzaC.2017 revised classification of seizures. Available at:https:\/\/www.epilepsy.com\/article\/2016\/12\/2017\u2010revised\u2010classification\u2010seizures. Accessed August 2 2018."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0013-9580.2004.31203.x"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000150932.48688.BE"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000068024.20285.65"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.398"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2012.09.008"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jped.2015.07.003"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2017.01.011"},{"key":"e_1_2_10_20_1","unstructured":"European Medicines Agency.Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders.2010. Available at:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2010\/01\/WC500070043.pdf. Accessed May 30 2019."},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-21.1.98"}],"container-title":["Epilepsia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fepi.16466","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/epi.16466","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/epi.16466","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/epi.16466","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T15:25:15Z","timestamp":1694013915000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/epi.16466"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,18]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,4]]}},"alternative-id":["10.1111\/epi.16466"],"URL":"https:\/\/doi.org\/10.1111\/epi.16466","archive":["Portico"],"relation":{},"ISSN":["0013-9580","1528-1167"],"issn-type":[{"value":"0013-9580","type":"print"},{"value":"1528-1167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,18]]},"assertion":[{"value":"2019-09-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-02-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}