Perampanel Study 207: long-term open-label evaluation in
patients with epilepsy

J 2012

Perampanel Study 207: long-term open-label evaluation in patients with epilepsy

REKTOR, Ivan, G. L. KRAUSS, M. BAR, V. BITON, J. A. KLAPPER et. al.

Základní údaje

Originální název

Perampanel Study 207: long-term open-label evaluation in patients with epilepsy

Autoři

REKTOR, Ivan (203 Česká republika, garant, domácí), G. L. KRAUSS (840 Spojené státy), M. BAR (203 Česká republika), V. BITON (840 Spojené státy), J. A. KLAPPER (840 Spojené státy), N. VAICIENE-MAGISTRIS (428 Lotyšsko), Robert KUBA (203 Česká republika, domácí), D. SQUILLACOTE (840 Spojené státy), M. GEE (826 Velká Británie a Severní Irsko) a D. KUMAR (840 Spojené státy)

Vydání

Acta Neurologica Scandinavica, Hoboken, WILEY-BLACKWELL, 2012, 0001-6314

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30000 3. Medical and Health Sciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.474

Kód RIV

RIV/00216224:14740/12:00073090

Organizační jednotka

Středoevropský technologický institut

DOI

http://dx.doi.org/10.1111/ane.12001

UT WoS

000308205500008

Klíčová slova anglicky

a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic

Štítky

ok, podil, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 4. 2014 08:39, Olga Křížová

Anotace

V originále

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.

Přiložené soubory

ZVV_2012_002_1181016_Perampanel_Study_207.pdf

Požádat o autorskou verzi souboru

Citovat

REKTOR, Ivan, G. L. KRAUSS, M. BAR, V. BITON, J. A. KLAPPER, N. VAICIENE-MAGISTRIS, Robert KUBA, D. SQUILLACOTE, M. GEE a D. KUMAR. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurologica Scandinavica. Hoboken: WILEY-BLACKWELL, 2012, roč. 126, č. 4, s. 263-269. ISSN 0001-6314. Dostupné z: https://dx.doi.org/10.1111/ane.12001.

@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 a D. KUMAR. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. \textit{Acta Neurologica Scandinavica}. Hoboken: WILEY-BLACKWELL, 2012, roč.~126, č.~4, s.~263-269. ISSN~0001-6314. Dostupné z: https://dx.doi.org/10.1111/ane.12001.

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