{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:10:24Z","timestamp":1789783824939,"version":"4.0.1"},"reference-count":21,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2006,1,10]],"date-time":"2006-01-10T00:00:00Z","timestamp":1136851200000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2006,1]]},"abstract":"<jats:p><jats:bold>Summary:\u2002<\/jats:bold><jats:italic>Purpose:<\/jats:italic>To assess the efficacy and safety of adjunctive levetiracetam (LEV) therapy in controlling partial\u2010onset seizures refractory to other antiepileptic drugs (AEDs) in a multicenter study in Taiwanese adults.<\/jats:p><jats:p><jats:italic>Methods:<\/jats:italic>Ninety\u2010four patients aged 16\u201360 years with refractory partial seizures were randomized to receive LEV (n = 47) or placebo (47) for 14 weeks and composed the intention\u2010to\u2010treat (ITT) population. After the first 2 weeks, LEV patients had their dosage increased from 500 mg twice daily to 1,000 mg twice daily. A 12\u2010week maintenance phase followed, after which patients switched to long\u2010term, open\u2010label LEV therapy or entered a 4\u2010week phase of medication discontinuation.<\/jats:p><jats:p><jats:italic>Results:<\/jats:italic>All patients from the ITT population, except one LEV\u2010treated patient with missing seizure\u2010count data, were included in the primary efficacy analysis. The least square mean of logarithmically transformed weekly partial\u2010seizure frequency was significantly lower in the LEV than in the placebo group (0.813 vs. 1.085; p = 0.001). LEV reduced log\u2010transformed weekly partial\u2010seizure frequency by 23.8% (95% confidence interval, 10.4\u201335.2%) relative to placebo. Significantly more LEV than placebo patients (43.5% vs. 10.6%) experienced a response of a \u226550% decrease from baseline in weekly frequency of partial seizures [odds ratio, 6.5 (95% CI, 2.2\u201319.3); p &lt; 0.001]. Adverse events were reported in 34 (72.3%) of 47 LEV\u2010treated patients and 32 (68.1%) of 47 placebo patients. The three most common adverse events in the LEV and placebo groups were somnolence (40.4% and 14.9%), dizziness (14.9% and 8.5%), and headache (10.6% and 8.5%), respectively. Only four patients (three LEV\u2010treated patients and one placebo patient) were withdrawn from the study because of adverse events.<\/jats:p><jats:p><jats:italic>Conclusions:<\/jats:italic>Adjunctive LEV therapy, \u22641,000 mg twice daily, was significantly more effective than placebo and was generally well tolerated in Taiwanese adults with treatment\u2010resistant partial\u2010onset seizures.<\/jats:p>","DOI":"10.1111\/j.1528-1167.2006.00372.x","type":"journal-article","created":{"date-parts":[[2006,1,10]],"date-time":"2006-01-10T15:01:52Z","timestamp":1136905312000},"page":"72-81","source":"Crossref","is-referenced-by-count":59,"title":["Efficacy and Safety of Levetiracetam (up to 2000 mg\/day) in Taiwanese Patients with Refractory Partial Seizures: A Multicenter, Randomized, Double\u2010blind, Placebo\u2010controlled Study"],"prefix":"10.1111","volume":"47","author":[{"given":"Jing\u2010Jane","family":"Tsai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Der\u2010Jen","family":"Yen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mo\u2010Song","family":"Hsih","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shung\u2010Sheng","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard","family":"Hiersemenzel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Edrich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chi\u2010Wan","family":"Lai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2006,1,10]]},"reference":[{"key":"e_1_2_6_2_2","first-page":"426","article-title":"A new antiepileptic drug","volume":"72","author":"Shorvon SD","year":"2002","journal-title":"J Neurol Neurosurg Psychiatry"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0920-1211(01)00296-0"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0920-1211(01)00287-X"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.2.236"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.2000.tb00323.x"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.2000.tb04605.x"},{"key":"e_1_2_6_8_2","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: ethnic factors in the acceptability of foreign clinical data E5. Recommended for Adoption at Step 4 of the ICH Process on 5 February 1998 by the ICH Steering Committee (including Post Step 4 corrections agreed by the Steering Committee on 11 March 1998). Accessible athttp:\/\/www.ich.org."},{"key":"e_1_2_6_9_2","unstructured":"Announcement of Bridging Study Department of Health Taiwan. Accessible athttp:\/\/www.cde.org.tw\/BS.web.cht\/main.htm"},{"key":"e_1_2_6_10_2","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6. Recommended for Adoption at Step 4 of the ICH Process on 1 May 1996 by the ICH Steering Committee (including Post Step 4 corrections agreed by the Steering Committee on 10 June 1996). 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