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. doi:10.1111/ane.12001.
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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 D. KUMAR (840 Spojené státy).
Vydání Acta Neurologica Scandinavica, Hoboken, WILEY-BLACKWELL, 2012, 0001-6314.
Další údaje
Originální 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
WWW 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
Změnil Změnila: Olga Křížová, učo 56639. Změněno: 25. 4. 2014 08:39.
Anotace
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.
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