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    Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial

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    Author
    French, JA; Krauss, GL; Wechsler, RT; Wang, X-F; DiVentura, B; Brandt, C; Trinka, E; O'Brien, TJ; Laurenza, A; Patten, A; ...
    Date
    2015-09-15
    Source Title
    Neurology
    Publisher
    LIPPINCOTT WILLIAMS & WILKINS
    University of Melbourne Author/s
    O'Brien, Terence
    Affiliation
    Medicine and Radiology
    Metadata
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    Document Type
    Journal Article
    Citations
    French, J. A., Krauss, G. L., Wechsler, R. T., Wang, X. -F., DiVentura, B., Brandt, C., Trinka, E., O'Brien, T. J., Laurenza, A., Patten, A. & Bibbiani, F. (2015). Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial. NEUROLOGY, 85 (11), pp.950-957. https://doi.org/10.1212/WNL.0000000000001930.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/257705
    DOI
    10.1212/WNL.0000000000001930
    Abstract
    OBJECTIVE: To assess efficacy and safety of adjunctive perampanel in patients with drug-resistant, primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE). METHODS: In this multicenter, double-blind study (ClinicalTrials.gov identifier: NCT01393743; funded by Eisai Inc.), patients 12 years or older with PGTC seizures and IGE were randomized to placebo or perampanel during a 4-week titration period (perampanel up titrated from 2 to 8 mg/d, or highest tolerated dose) and 13-week maintenance period. The primary endpoint was percent change in PGTC seizure frequency per 28 days (titration plus maintenance vs baseline). The key secondary endpoint (primary endpoint for European Union registration) was 50% PGTC seizure responder rate (patients achieving $50% reduction in PGTC seizure frequency; maintenance vs baseline). Treatment-emergent adverse events were monitored. RESULTS: Of 164 randomized patients, 162 comprised the full analysis set (placebo, 81; perampanel, 81). Compared with placebo, perampanel conferred a greater median percent change in PGTC seizure frequency per 28 days (238.4%vs 276.5%; p , 0.0001) and greater 50%PGTC seizure responder rate (39.5% vs 64.2%; p 5 0.0019). During maintenance, 12.3% of placebo treated patients and 30.9%of perampanel-treated patients achieved PGTC seizure freedom. For the safety analysis (placebo, 82; perampanel, 81), the most frequent treatment-emergent adverse events with perampanel were dizziness (32.1%) and fatigue (14.8%). CONCLUSIONS: Adjunctive perampanel was well tolerated and improved control of drug-resistant PGTC seizures in patients with IGE. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that adjunctive perampanel reduces PGTC seizure frequency, compared with placebo, in patients with drug-resistant PGTC seizures in IGE.

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