{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T10:32:23Z","timestamp":1777804343738,"version":"3.51.4"},"reference-count":17,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2019,1,27]],"date-time":"2019-01-27T00:00:00Z","timestamp":1548547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Child Neurol"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:p>\n                    Efficacy and safety of pregabalin as adjunctive treatment for children (aged 4-16 years) with partial-onset seizures, hereafter termed focal onset seizures for this study, was evaluated. This double-blind, randomized, placebo-controlled, international study had 3 phases: 8-week baseline, 12-week double-blind treatment (2-week dose escalation; 10-week fixed dose), and 1-week taper. Selection criteria included experiencing focal onset seizures and receiving a stable regimen of 1 to 3 antiepileptic drugs. Study treatments were pregabalin 2.5 mg\/kg\/d, 10 mg\/kg\/d, or placebo; doses were increased to 3.5 or 14 mg\/kg\/d for subjects weighing &lt;30 kg. The key endpoints were change in log\n                    <jats:sub>e<\/jats:sub>\n                    (28-day seizure rate), achieving a \u226550% seizure responder rate, safety, and tolerability during double-blind treatment. Subjects (n = 295; mean age 10.2 years, 55% male, 69% white) were randomized to pregabalin 2.5 mg\/kg\/d (n = 104), 10 mg\/kg\/d (n = 97), or placebo (n = 94). A statistically significant reduction in log\n                    <jats:sub>e<\/jats:sub>\n                    (28-day seizure rate) was demonstrated with pregabalin 10 mg\/kg\/d (a 19.9% improvement over placebo; P = .0185). Seizure frequency was numerically improved (statistically nonsignificant) with pregabalin 2.5 mg\/kg\/d ( P = .2577). Responder rate significantly favored pregabalin 10 mg\/kg\/d (40.6%, P = .0068) compared with placebo (22.6%) and was numerically improved with pregabalin 2.5 mg\/kg\/d (29.1%, P = .2600). Common adverse events (\u226510% of any group) in 10 mg\/kg\/d, 2.5 mg\/kg\/d, and placebo groups, respectively, included somnolence (25.8%, 17.3%, 13.8%), increased weight (13.4%, 3.8%, 4.3%), and increased appetite (10.3%, 6.7%, 4.3%). Pregabalin 10 mg\/kg\/d demonstrated efficacy in seizure frequency reduction in children with focal onset seizures compared with placebo, and both pregabalin doses were generally safe and well tolerated.\n                  <\/jats:p>\n                  <jats:p>www.clinicialtrials.gov identifier NCT01389596; EudraCT #2010-020852-79<\/jats:p>","DOI":"10.1177\/0883073818821035","type":"journal-article","created":{"date-parts":[[2019,1,28]],"date-time":"2019-01-28T02:21:16Z","timestamp":1548642076000},"page":"248-255","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":17,"title":["Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial"],"prefix":"10.1177","volume":"34","author":[{"given":"Jeremias","family":"Antinew","sequence":"first","affiliation":[{"name":"Pfizer Global Research and Development, Groton, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruno","family":"Pitrosky","sequence":"additional","affiliation":[{"name":"Pfizer Global Product Development Group, Paris, France"},{"name":"Affiliation at the time of the study"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lloyd","family":"Knapp","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development, Groton, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Almas","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Verne","family":"Pitman","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development, Groton, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Liu","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development, Groton, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dana","family":"Craiu","sequence":"additional","affiliation":[{"name":"Pediatric Neurology Discipline, Neurosciences Department, Carol Davila University of Medicine, Bucharest, Romania"}],"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":"Douglas","family":"Nordli","sequence":"additional","affiliation":[{"name":"Neuroscience Institute at Children\u2019s Hospital Los Angeles, Los Angeles, CA, USA"}],"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"}]}],"member":"179","published-online":{"date-parts":[[2019,1,27]]},"reference":[{"key":"bibr1-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1684\/epd.2015.0736"},{"key":"bibr2-0883073818821035","unstructured":"Lyrica (pregabalin) [US prescribing information]. Updated December 2016. http:\/\/labeling.pfizer.com\/ShowLabeling.aspx?id=561. Accessed March 5, 2018."},{"key":"bibr3-0883073818821035","unstructured":"European Medicines Agency. Lyrica (pregabalin) summary of product characteristics. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000546\/WC500046602.pdf. Updated January 15, 2018. Accessed March 5, 2018."},{"key":"bibr4-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000068024.20285.65"},{"key":"bibr5-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/j.0013-9580.2004.31203.x"},{"key":"bibr6-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000150932.48688.BE"},{"key":"bibr7-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/j.0013-9580.2004.455003.x"},{"key":"bibr8-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12830"},{"key":"bibr9-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2010.02522.x"},{"key":"bibr10-0883073818821035","unstructured":"Fisher RS, Shafer PO, D\u2019Souza C. 2017 revised classification of seizures. https:\/\/www.epilepsy.com\/article\/2016\/12\/2017-revised-classification-seizures. Accessed December 11, 2017."},{"key":"bibr11-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2016.1246536"},{"issue":"1","key":"bibr12-0883073818821035","first-page":"98","volume":"21","author":"Pediatric News","year":"2016","journal-title":"J Pediatr Pharmacol Ther"},{"key":"bibr13-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1002\/ana.21642"},{"key":"bibr14-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12862"},{"issue":"4","key":"bibr15-0883073818821035","doi-asserted-by":"crossref","first-page":"989","DOI":"10.1093\/brain\/awn357","volume":"132","author":"Sillanp\u00e4\u00e4 M","year":"2009","journal-title":"Brain"},{"key":"bibr16-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2010.02969.x"},{"key":"bibr17-0883073818821035","doi-asserted-by":"publisher","DOI":"10.1046\/j.1528-1157.43.s.3.3.x"}],"container-title":["Journal of Child Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0883073818821035","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0883073818821035","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0883073818821035","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:39:45Z","timestamp":1777495185000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0883073818821035"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,27]]},"references-count":17,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2019,4]]}},"alternative-id":["10.1177\/0883073818821035"],"URL":"https:\/\/doi.org\/10.1177\/0883073818821035","relation":{},"ISSN":["0883-0738","1708-8283"],"issn-type":[{"value":"0883-0738","type":"print"},{"value":"1708-8283","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,27]]}}}