{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T03:51:14Z","timestamp":1788580274728,"version":"build-2803163510"},"reference-count":19,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2013,7,9]],"date-time":"2013-07-09T00:00:00Z","timestamp":1373328000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2013,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To assess the efficacy and safety\/tolerability of adjunctive zonisamide treatment in pediatric patients with partial epilepsy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>, double\u2010blind, randomized, placebo\u2010controlled, multicenter trial, 207 patients (age 6\u201317\u00a0years) with partial epilepsy, receiving one or two antiepileptic drugs, were randomized to receive adjunctive zonisamide or placebo. Zonisamide was initiated at 1\u00a0mg\/kg\/day, titrated to a target dose of 8\u00a0mg\/kg\/day over 8\u00a0weeks (one down\u2010titration permitted), and maintained for 12\u00a0weeks. The primary efficacy end point was the proportion of responders (\u226550% seizure frequency reduction from baseline) during the 12\u2010week maintenance period. Safety\/tolerability assessments included the incidence of treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Findings<\/jats:title><jats:p>In total, 93 (86.9%) of 107 patients randomized to zonisamide and 90 (90.0%) of 100 patients randomized to placebo completed the trial. Responder rates were 50% for zonisamide versus 31% for placebo (p\u00a0=\u00a00.0044; intention\u2010to\u2010treat population, last observation carried forward). The overall incidence of <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s was similar for zonisamide (55.1%) versus placebo (50.0%), with low rates of serious <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s with zonisamide and placebo (3.7% vs. 2.0%) and <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s leading to withdrawal (0.9% vs. 3.0%). <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s reported more frequently with zonisamide versus placebo were decreased appetite (6.5% vs. 4.0%), decreased weight (4.7% vs. 3.0%), somnolence (4.7% vs. 2.0%), vomiting (3.7% vs. 2.0%), and diarrhea (3.7% vs. 1.0%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Adjunctive zonisamide treatment was shown to be effective and well tolerated in pediatric patients with partial epilepsy. No new or unexpected safety findings emerged.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.12233","type":"journal-article","created":{"date-parts":[[2013,7,9]],"date-time":"2013-07-09T14:51:16Z","timestamp":1373381476000},"page":"1473-1480","source":"Crossref","is-referenced-by-count":52,"title":["A randomized phase <scp>III<\/scp> trial of adjunctive zonisamide in pediatric patients with partial epilepsy"],"prefix":"10.1111","volume":"54","author":[{"given":"Renzo","family":"Guerrini","sequence":"first","affiliation":[{"name":"Children's Hospital Anna Meyer\u2013University of Florence Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Rosati","sequence":"additional","affiliation":[{"name":"Children's Hospital Anna Meyer\u2013University of Florence Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Segieth","sequence":"additional","affiliation":[{"name":"Eisai Ltd Hatfield United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Pellacani","sequence":"additional","affiliation":[{"name":"Children's Hospital Anna Meyer\u2013University of Florence Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Bradshaw","sequence":"additional","affiliation":[{"name":"Eisai Ltd Hatfield United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Giorgi","sequence":"additional","affiliation":[{"name":"Eisai Ltd Hatfield United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,7,9]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1999.tb00833.x"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1999.tb00739.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.4.4.421"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/wnf.0b013e3180413d7d"},{"key":"e_1_2_7_6_1","first-page":"53","article-title":"Long\u2010term tolerability of zonisamide in paediatric patients with epilepsy: results of a Phase II, open\u2010label, extension study","volume":"53","author":"Chouette I","year":"2012","journal-title":"Epilepsia"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.53.8.1724"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.52.7.1338"},{"key":"e_1_2_7_9_1","first-page":"53","article-title":"Pharmacokinetics and tolerability of zonisamide in paediatric patients with epilepsy: results of a Phase II, open\u2010label study","volume":"53","author":"Giorgi L","year":"2012","journal-title":"Epilepsia"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.54.12.2237"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000217916.00225.3a"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1981.tb06159.x"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200002033420503"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774510361974"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000285493.08622.35"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050166"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2010.517194"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0404.2008.01119.x"},{"key":"e_1_2_7_19_1","unstructured":"Zonegran\u00aePrescribing Information Eisai. 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