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@article{1089111,
author = {Krauss, G.L. and Bar, M. and Biton, V. and Klapper, J.A. and Rektor, Ivan and VaicieneandMagistris, N. and Squillacote, D. and Gupta, Dwijendra Kumar},
article_location = {MALDEN},
article_number = {1},
doi = {http://dx.doi.org/10.1111/j.1600-0404.2011.01588.x},
keywords = {antiepileptic drugs; efficacy; partial-onset; perampanel; refractory; safety},
language = {eng},
issn = {0001-6314},
journal = {Acta Neurologica Scandinavica},
title = {Tolerability and safety of perampanel: two randomized dose-escalation studies},
volume = {125},
year = {2012}
}
TY - JOUR
ID - 1089111
AU - Krauss, G.L. - Bar, M. - Biton, V. - Klapper, J.A. - Rektor, Ivan - Vaiciene-Magistris, N. - Squillacote, D. - Gupta, Dwijendra Kumar
PY - 2012
TI - Tolerability and safety of perampanel: two randomized dose-escalation studies
JF - Acta Neurologica Scandinavica
VL - 125
IS - 1
SP - 8-15
EP - 8-15
PB - WILEY-BLACKWELL
SN - 00016314
KW - antiepileptic drugs
KW - efficacy
KW - partial-onset
KW - perampanel
KW - refractory
KW - safety
N2 - Objectives - To evaluate, for the first time in patients with epilepsy, the tolerability and safety of escalating doses of oral perampanel, a novel, selective, non-competitive AMPA antagonist, as adjunctive therapy for refractory partial-onset seizures. Materials and methods - Two consecutive, randomized, double-blind, dose-escalation studies recruited adults (18-70 years) with uncontrolled partial-onset seizures receiving one to three concomitant antiepileptic drugs. In study 206, patients were treated for 12 weeks (8-week dose-titration, 4-week dose-maintenance) with placebo or perampanel (up to 4 mg/day, dosed once-or twice-daily). In study 208, patients received placebo or perampanel once-daily (up to 12 mg) for 16 weeks (12-week titration, 4-week maintenance). Results - Overall, 153 patients were randomized into study 206 (perampanel twice-daily, n = 51; perampanel once-daily, n = 51; placebo, n = 51). Study 208 included 48 patients (perampanel once-daily, n = 38; placebo, n = 10). The highest dose in study 206 - 4 mg/day - was well tolerated, with similar proportions of patients tolerating once-daily (82.4%) and twice-daily (82.4%) perampanel and placebo (82.4%) treatments. In study 208 most patients tolerated doses of 6 mg perampanel once-daily in a Kaplan-Meier analysis. In both studies, the most common adverse events were CNS-related; most were of mild/moderate severity. Conclusions Perampanel was well tolerated across doses of 4-12 mg/day. The studies showed preliminary evidence of efficacy and identified doses to be evaluated in larger clinical studies.
ER -
KRAUSS, G.L., M. BAR, V. BITON, J.A. KLAPPER, Ivan REKTOR, N. VAICIENE-MAGISTRIS, D. SQUILLACOTE and Dwijendra Kumar GUPTA. Tolerability and safety of perampanel: two randomized dose-escalation studies. \textit{Acta Neurologica Scandinavica}. MALDEN: WILEY-BLACKWELL, 2012, vol.~125, No~1, p.~8-15. ISSN~0001-6314. Available from: https://dx.doi.org/10.1111/j.1600-0404.2011.01588.x.
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