A randomized, double-blind, double-dummy, multicenter trial comparing the efficacy and safety of extended- and immediate-release levetiracetam in people with partial epilepsy

Tony Wu, Siew Na Lim, Jing Jane Tsai, Yao Chung Chuang, Chin Wei Huang, Chun Chieh Lin, Chang Hung Hsu, Hong Chung Fung, Chih Hong Lee

Research output: Contribution to journalArticle

Abstract

Purpose: The aim of this trial was to compare the efficacy and safety of two formulations of levetiracetam in people with partial epilepsy over a 12-week treatment period. Methods: We performed a randomized, paralleled, and multicenter trial that consisted of a 4-week single-blind placebo run-in, followed by a 12-week double-blind, double-dummy treatment phase to compare the efficacy and safety of levetiracetam extended-release (LEV-ER) and immediate-release (LEV-IR) tablets as an adjunctive treatment in adult patients with uncontrolled epilepsy. Results: The median partial-onset seizure (POS) frequency per week (min-max) was 0.3 (0.0, 17.4; 95% confidence interval [95% CI] 1.3, 4.8) in the LEV-ER group and 0.3 (0.0, 31.4; 95% CI − 0.1, 4.3) in the LEV-IR group. No serious adverse events occurred during the trial period. Both groups had the same responder rate (58.6%), while a higher rate of seizure freedom over the treatment period was noted in the LEV-ER group compared with the LEV-IR group (27.6% vs. 13.8%, respectively). The European Quality of Life–5 Dimensions scores significantly increased in the LEV-ER–treated group, in contrast to the scores in the LEV-IR group, which decreased (7.2 vs. − 1.5, p = 0.03). Conclusion: These results suggest that LEV-ER is equivalent to LEV-IR in reducing the frequency of POS and has a similar tolerability as LEV-IR as an add-on therapy. In addition, LEV-ER treatment improved the health-related quality of life of people with uncontrolled partial epilepsy.

Original languageEnglish
Pages (from-to)84-90
Number of pages7
JournalSeizure
Volume62
DOIs
Publication statusPublished - 2018 Nov

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

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