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. Acta Neurologica Scandinavica. Hoboken: WILEY-BLACKWELL, 2012, vol. 126, No 4, p. 263-269. ISSN 0001-6314. doi:10.1111/ane.12001.
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Basic information
Original name Perampanel Study 207: long-term open-label evaluation in patients with epilepsy
Authors REKTOR, Ivan (203 Czech Republic, guarantor, belonging to the institution), G. L. KRAUSS (840 United States of America), M. BAR (203 Czech Republic), V. BITON (840 United States of America), J. A. KLAPPER (840 United States of America), N. VAICIENE-MAGISTRIS (428 Latvia), Robert KUBA (203 Czech Republic, belonging to the institution), D. SQUILLACOTE (840 United States of America), M. GEE (826 United Kingdom of Great Britain and Northern Ireland) and D. KUMAR (840 United States of America).
Edition Acta Neurologica Scandinavica, Hoboken, WILEY-BLACKWELL, 2012, 0001-6314.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30000 3. Medical and Health Sciences
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 2.474
RIV identification code RIV/00216224:14740/12:00073090
Organization unit Central European Institute of Technology
Doi http://dx.doi.org/10.1111/ane.12001
UT WoS 000308205500008
Keywords in English a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic
Tags ok, podil, rivok
Tags International impact, Reviewed
Changed by Changed by: Olga Křížová, učo 56639. Changed: 25. 4. 2014 08:39.
Abstract
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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