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

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Title:	Perampanel Study 207: long-term open-label evaluation in patients with epilepsy.
Authors:	Rektor, I., Krauss, G. L., Bar, M., Biton, V., Klapper, J. A., Vaiciene-Magistris, N., Kuba, R., Squillacote, D., Gee, M., Kumar, D.
Source:	Acta Neurologica Scandinavica. Oct2012, Vol. 126 Issue 4, p263-269. 7p. 5 Charts, 1 Graph.
Subjects:	Treatment of epilepsy, AMPA receptor antagonists, Drug efficacy, Headache, Adverse health care events, Spasms, Drowsiness
Abstract:	Objectives Evaluate interim long-term tolerability, safety and efficacy of adjunctive perampanel, a novel α-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 (18-70 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. [ABSTRACT FROM AUTHOR]
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Database:	Psychology and Behavioral Sciences Collection

Description
Abstract:	Objectives Evaluate interim long-term tolerability, safety and efficacy of adjunctive perampanel, a novel α-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 (18-70 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. [ABSTRACT FROM AUTHOR]
ISSN:	00016314
DOI:	10.1111/ane.12001