Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures

Authors

  • A. Gil-Nagel,

    1. Hospital Ruber Internacional, La Masó 38, Mirasierra, Madrid, Spain
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  • J. Lopes-Lima,

    1. Hospital Santo António, Largo Prof. Abel Salazar, Porto, Portugal
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  • L. Almeida,

    1. Department of Research and Development, BIAL – Portela & Co SA, À Avenida da Siderurgia Nacional, S. Mamede do Coronado, Portugal
    2. Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal
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  • J. Maia,

    1. Department of Research and Development, BIAL – Portela & Co SA, À Avenida da Siderurgia Nacional, S. Mamede do Coronado, Portugal
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  • P. Soares-da-Silva,

    1. Department of Research and Development, BIAL – Portela & Co SA, À Avenida da Siderurgia Nacional, S. Mamede do Coronado, Portugal
    2. Institute of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal
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  • on behalf of the BIA-2093-303 Investigators Study Group

    1. Hospital Ruber Internacional, La Masó 38, Mirasierra, Madrid, Spain
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P. Soares-da-Silva, Department of Research and Development, BIAL – Portela & Co SA, À Avenida da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
e-mail: psoares.silva@bial.com

Abstract

Objectives  –  To evaluate the efficacy and safety of eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.

Material and methods  –  Double-blind, placebo-controlled, parallel-group, multicenter study consisting of an 8-week baseline period, after which patients were randomized to placebo (n = 87) or once-daily ESL 800 mg (n = 85) or 1200 mg (n = 80). Patients received half dose during 2 weeks preceding a 12-week maintenance period.

Results  –  Seizure frequency over the maintenance period was significantly (P < 0.05) lower than placebo in both ESL groups. Responder rate was 23% (placebo), 35% (800 mg), and 38% (1200 mg). Median relative reduction in seizure frequency was 17% (placebo), 38% (800 mg), and 42% (1200 mg). The most common adverse events (AEs) (>10%) were dizziness, somnolence, headache, and nausea. The majority of AEs were of mild or moderate severity.

Conclusions  –  Once-daily treatment with ESL 800 and 1200 mg was effective and generally well tolerated.

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