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

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An Entity of Type : http://linked.opendata.cz/ontology/domain/vavai/Vysledek, within Data Space : linked.opendata.cz associated with source document(s)

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rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
Description	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. 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. (en)
Title	Perampanel Study 207: long-term open-label evaluation in patients with epilepsy Perampanel Study 207: long-term open-label evaluation in patients with epilepsy (en)
skos:prefLabel	Perampanel Study 207: long-term open-label evaluation in patients with epilepsy Perampanel Study 207: long-term open-label evaluation in patients with epilepsy (en)
skos:notation	RIV/00216224:14740/12:00073090!RIV14-MSM-14740___
http://linked.open...avai/riv/aktivita	I N
http://linked.open...avai/riv/aktivity	I, N
http://linked.open...iv/cisloPeriodika	4
http://linked.open...vai/riv/dodaniDat	2014
http://linked.open...aciTvurceVysledku	Kuba, Robert Rektor, Ivan
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Masarykova univerzita / Středoevropský technologický institut
http://linked.open...dnocenehoVysledku	158140
http://linked.open...ai/riv/idVysledku	RIV/00216224:14740/12:00073090
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic (en)
http://linked.open.../riv/klicoveSlovo	glutamate a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid antiepileptic drugs long-term safety open-label extension perampanel post-synaptic epilepsy
http://linked.open...odStatuVydavatele	US - Spojené státy americké
http://linked.open...ontrolniKodProRIV	[F9F5C50880D1]
http://linked.open...i/riv/nazevZdroje	Acta Neurologica Scandinavica
http://linked.open...in/vavai/riv/obor	FH
http://linked.open...ichTvurcuVysledku	2 (xsd:int)
http://linked.open...cetTvurcuVysledku	10 (xsd:int)
http://linked.open...UplatneniVysledku	2012
http://linked.open...v/svazekPeriodika	126
http://linked.open...iv/tvurceVysledku	Kuba, Robert Rektor, Ivan Bar, M. Biton, V. Gee, M. Klapper, J. A. Krauss, G. L. Kumar, D. Squillacote, D. Vaiciene-Magistris, N.
http://linked.open...ain/vavai/riv/wos	000308205500008
issn	0001-6314
number of pages	7 (xsd:int)
http://bibframe.org/vocab/doi	10.1111/ane.12001
http://localhost/t...ganizacniJednotka	14740

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