{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T20:52:18Z","timestamp":1790369538018,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2004,5,14]],"date-time":"2004-05-14T00:00:00Z","timestamp":1084492800000},"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":[[2004,6]]},"abstract":"<jats:p><jats:bold>Summary:\u2003<\/jats:bold>  <jats:italic>Purpose:<\/jats:italic> This study was designed to evaluate efficacy and safety of zonisamide (ZNS) as adjunctive treatment for patients with refractory partial seizures.<\/jats:p><jats:p> <jats:italic>Methods:<\/jats:italic> This randomized, double\u2010blind, placebo\u2010controlled study was conducted at four epilepsy treatment centers. It included a baseline phase (8 to 12 weeks) and a double\u2010blind treatment phase (12 weeks). Initially, patients randomized to ZNS treatment were given a 7\u2010mg\/kg\/d dosage. When investigators found that adverse effects could be reduced by gradually introducing ZNS, patients were allowed to begin treatment at lower doses (100 mg or \u223c1.5 mg\/kg\/d) titrated over several weeks to a maximum of 400 to 600 mg\/d. Primary and secondary efficacy measures were the median percentage reduction from baseline in seizure frequency and the proportion of patients achieving a \u226550% reduction from baseline (responder rate). Patient and physician global assessments also served as indicators of efficacy. Safety was assessed primarily by treatment\u2010emergent adverse events.<\/jats:p><jats:p> <jats:italic>Results:<\/jats:italic> ZNS\u2010treated patients had a 28.9% reduction in seizure frequency, which differed significantly from the 4.7% increase in placebo\u2010treated patients. The responder rate for ZNS\u2010treated patients was 26.9%, compared with 16.2% for placebo\u2010treated patients. At study's end, 66.2% of ZNS\u2010treated patients and 12.3% of placebo\u2010treated patients considered their condition improved; similarly, physicians assessed 63.6% of ZNS\u2010treated patients and 10.8% of placebo\u2010treated patients as improved. The most frequently reported adverse events with ZNS treatment included somnolence, irritability, dizziness, nausea, and fatigue.<\/jats:p><jats:p> <jats:italic>Conclusions:<\/jats:italic> As adjunctive treatment, ZNS was generally well tolerated and significantly improved seizure control among patients with refractory partial seizures.<\/jats:p>","DOI":"10.1111\/j.0013-9580.2004.11403.x","type":"journal-article","created":{"date-parts":[[2004,5,14]],"date-time":"2004-05-14T13:43:22Z","timestamp":1084542202000},"page":"610-617","source":"Crossref","is-referenced-by-count":113,"title":["Randomized, Controlled Clinical Trial of Zonisamide as Adjunctive Treatment for Refractory Partial Seizures"],"prefix":"10.1111","volume":"45","author":[{"given":"J. Chris","family":"Sackellares","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. 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