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@article{1181016,
author = {Rektor, Ivan and Krauss, G. L. and Bar, M. and Biton, V. and Klapper, J. A. and VaicieneandMagistris, N. and Kuba, Robert and Squillacote, D. and Gee, M. and Kumar, D.},
article_location = {Hoboken},
article_number = {4},
doi = {http://dx.doi.org/10.1111/ane.12001},
keywords = {a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic},
language = {eng},
issn = {0001-6314},
journal = {Acta Neurologica Scandinavica},
title = {Perampanel Study 207: long-term open-label evaluation in patients with epilepsy},
url = {http://onlinelibrary.wiley.com/doi/10.1111/ane.12001/abstract},
volume = {126},
year = {2012}
}
TY - JOUR
ID - 1181016
AU - Rektor, Ivan - Krauss, G. L. - Bar, M. - Biton, V. - Klapper, J. A. - Vaiciene-Magistris, N. - Kuba, Robert - Squillacote, D. - Gee, M. - Kumar, D.
PY - 2012
TI - Perampanel Study 207: long-term open-label evaluation in patients with epilepsy
JF - Acta Neurologica Scandinavica
VL - 126
IS - 4
SP - 263-269
EP - 263-269
PB - WILEY-BLACKWELL
SN - 00016314
KW - a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid
KW - antiepileptic drugs
KW - epilepsy
KW - glutamate
KW - long-term safety
KW - open-label extension
KW - perampanel
KW - post-synaptic
UR - http://onlinelibrary.wiley.com/doi/10.1111/ane.12001/abstract
N2 - Objectives Evaluate interim long-term tolerability, safety and efficacy of adjunctive perampanel, a novel alpha-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid (AMPA)-receptor antagonist, in patients with refractory partial-onset seizures. Materials and methods Study 207, an open-label extension (OLE) study (ClinicalTrials.gov identifier: NCT00368472), enrolled patients (1870 years) who completed one of two randomized, placebo-controlled, dose-escalation Phase II studies. The OLE Treatment Phase comprised a 12-week Titration Period (2 mg increments of perampanel every 2 weeks to 12 mg/day, maximum) and a Maintenance Period, during which patients continued treatment up to a planned maximum of 424 weeks ( 8 years). Interim analysis data cut-off date was 1 December, 2010. Results Of 180 patients completing the Phase II studies, 138 enrolled in study 207. At the time of interim analyses (approximately 4 years after study start), over a third (n = 53, 38.4%) remained on perampanel; 41.3% (n = 57) of patients had >3 years of exposure; and 13.0% (n = 18) had at least 4 years' exposure. Mean +/- standard deviation (SD) duration of exposure was 116 +/- 75 weeks and mean +/- SD dose during the OLE Maintenance Period was 7.3 +/- 3.3 mg. No new safety signals emerged with long-term treatment. Consistent with previous studies, the most common treatment-emergent adverse events were as follows: dizziness, headache and somnolence. Overall median (range) per cent change from baseline in seizure frequency per 28 days during open-label treatment was -31.5% (-99.2 to 512.2). Conclusions Long-term up to 4 years adjunctive perampanel had a favourable tolerability profile in patients with refractory partial-onset seizures. Improvements in seizure control were maintained with long-term treatment.
ER -
REKTOR, Ivan, G. L. KRAUSS, M. BAR, V. BITON, J. A. KLAPPER, N. VAICIENE-MAGISTRIS, Robert KUBA, D. SQUILLACOTE, M. GEE and D. KUMAR. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. \textit{Acta Neurologica Scandinavica}. Hoboken: WILEY-BLACKWELL, 2012, vol.~126, No~4, p.~263-269. ISSN~0001-6314. Available from: https://dx.doi.org/10.1111/ane.12001.
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