{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T04:40:04Z","timestamp":1781584804869,"version":"3.54.5"},"reference-count":19,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2014,6,24]],"date-time":"2014-06-24T00:00:00Z","timestamp":1403568000000},"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":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2014,8]]},"abstract":"Summary<\/jats:title>Objectives<\/jats:title>To assess the efficacy and tolerability of add\u2010on pregabalin controlled\u2010release formulation (PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content>) (doses of 165 or 330\u00a0mg\/day) in patients with partial\u2010onset seizures (POS<\/jats:styled-content>).<\/jats:p><\/jats:sec>Methods<\/jats:title>This was a randomized, double\u2010blind (DB<\/jats:styled-content>), parallel\u2010group study of PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> once\u2010daily as adjunctive treatment in adults with treatment\u2010resistant partial seizures. After an 8\u2010week baseline period, eligible patients were randomized (1:1:1) to placebo, PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 165\u00a0mg, or PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 330\u00a0mg for 14\u00a0weeks, including a 2\u2010week dose escalation. Primary endpoint was the loge<\/jats:sub>\u2010transformed 28\u2010day seizure rate for all POS<\/jats:styled-content> with observable component during the full 14\u2010week double\u2010blind treatment phase. Secondary endpoints included the 50% responder rate and percent change from baseline in 28\u2010day POS<\/jats:styled-content> rate.<\/jats:p><\/jats:sec>Results<\/jats:title>Three hundred twenty\u2010three patients were randomized and received treatment; placebo (n\u00a0=\u00a0110), PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 330\u00a0mg (n\u00a0=\u00a0100), PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 165\u00a0mg (n\u00a0=\u00a0113); and 287 (88.9%) completed the trial. The primary efficacy analysis result, expressed as percent reduction from placebo, was 13.1% and 1.0% for PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 330\u00a0mg and PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> 165\u00a0mg, respectively, and was not statistically significant (p\u00a0=\u00a00.091, 0.908). The proportion of 50% responders was similar for placebo (35.8%) and 165\u00a0mg PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> (37.8%) and nominally higher for 330\u00a0mg PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> (45.9%, p\u00a0=\u00a00.125 compared to placebo). The LS<\/jats:styled-content> mean estimates of the percent change from baseline for placebo (\u22125.7%) was nominally smaller than 165\u00a0mg PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> (\u221215.0%, p\u00a0=\u00a00.540) and 330\u00a0mg PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> (\u221231.5%, p\u00a0=\u00a00.079); however, the median percent changes from baseline were not as well differentiated (placebo, \u221235.4%; 165 mg PGB\u2010CR, \u221238.0%; 330 mg PGB\u2010CR \u221243.4%). Rates of adverse events (AE<\/jats:styled-content>s) were low for placebo and study drug; the most frequent reported AE<\/jats:styled-content>s were dizziness, somnolence, and fatigue, consistent with the immediate\u2010release formulation.<\/jats:p><\/jats:sec>Significance<\/jats:title>Results from this trial did not demonstrate that PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> is effective in reducing seizure frequency below that of placebo. Both doses of PGB<\/jats:styled-content>\u2010CR<\/jats:styled-content> were shown to be safe and well\u2010tolerated.<\/jats:p>A PowerPoint slide summarizing this article is available for download in the Supporting Information section here<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.12690","type":"journal-article","created":{"date-parts":[[2014,6,24]],"date-time":"2014-06-24T21:45:51Z","timestamp":1403646351000},"page":"1220-1228","source":"Crossref","is-referenced-by-count":28,"title":["Adjunctive use of controlled\u2010release pregabalin in adults with treatment\u2010resistant partial seizures: A double\u2010blind, randomized, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"55","author":[{"given":"Jacqueline","family":"French","sequence":"first","affiliation":[{"name":"NYU Comprehensive Epilepsy Center New York New York U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Brandt","sequence":"additional","affiliation":[{"name":"Bethel Epilepsy Center Mara Hospital Bielefeld Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Friedman","sequence":"additional","affiliation":[{"name":"NYU Comprehensive Epilepsy Center New York New York U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Biton","sequence":"additional","affiliation":[{"name":"Arkansas Epilepsy Program Little Rock Arkansas U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lloyd","family":"Knapp","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Verne","family":"Pitman","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marci","family":"Chew","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Dubrava","sequence":"additional","affiliation":[{"name":"Pfizer Inc Groton Connecticut U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly B.","family":"Posner","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York New York U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,6,24]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.4065\/71.6.576"},{"key":"e_1_2_8_3_1","volume-title":"Epilepsy, fact sheet N\u00b0999, October 2012","author":"World Health Organization","year":"2012"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2011.03024.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0b013e3283507e73"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2012.02.002"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2012.18.7.527"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2008.12.006"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1086\/596482"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199222010-00002"},{"key":"e_1_2_8_11_1","volume-title":"LYRICA\u00ae US prescribing information","author":"Pfizer Inc","year":"2004"},{"key":"e_1_2_8_12_1","volume-title":"LYRICA\u00ae EU product information","author":"Pfizer Inc","year":"2009"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.2013.749239"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2013.01.602"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0013-9580.2004.31203.x"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000068024.20285.65"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182635735"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2010.02915.x"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000150932.48688.BE"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/AAP.0b013e3181fa6b7a"}],"container-title":["Epilepsia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fepi.12690","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/epi.12690","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T17:33:47Z","timestamp":1695490427000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/epi.12690"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,6,24]]},"references-count":19,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2014,8]]}},"alternative-id":["10.1111\/epi.12690"],"URL":"https:\/\/doi.org\/10.1111\/epi.12690","archive":["Portico"],"relation":{},"ISSN":["0013-9580","1528-1167"],"issn-type":[{"value":"0013-9580","type":"print"},{"value":"1528-1167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,6,24]]}}}