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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]
Copyright of Acta Neurologica Scandinavica is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Perampanel Study 207: long-term open-label evaluation in patients with epilepsy.
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  Data: <searchLink fieldCode="AR" term="%22Rektor%2C+I%2E%22">Rektor, I.</searchLink><br /><searchLink fieldCode="AR" term="%22Krauss%2C+G%2E+L%2E%22">Krauss, G. L.</searchLink><br /><searchLink fieldCode="AR" term="%22Bar%2C+M%2E%22">Bar, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Biton%2C+V%2E%22">Biton, V.</searchLink><br /><searchLink fieldCode="AR" term="%22Klapper%2C+J%2E+A%2E%22">Klapper, J. A.</searchLink><br /><searchLink fieldCode="AR" term="%22Vaiciene-Magistris%2C+N%2E%22">Vaiciene-Magistris, N.</searchLink><br /><searchLink fieldCode="AR" term="%22Kuba%2C+R%2E%22">Kuba, R.</searchLink><br /><searchLink fieldCode="AR" term="%22Squillacote%2C+D%2E%22">Squillacote, D.</searchLink><br /><searchLink fieldCode="AR" term="%22Gee%2C+M%2E%22">Gee, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Kumar%2C+D%2E%22">Kumar, D.</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Acta+Neurologica+Scandinavica%22">Acta Neurologica Scandinavica</searchLink>. Oct2012, Vol. 126 Issue 4, p263-269. 7p. 5 Charts, 1 Graph.
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  Data: <searchLink fieldCode="DE" term="%22Treatment+of+epilepsy%22">Treatment of epilepsy</searchLink><br /><searchLink fieldCode="DE" term="%22AMPA+receptor+antagonists%22">AMPA receptor antagonists</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+efficacy%22">Drug efficacy</searchLink><br /><searchLink fieldCode="DE" term="%22Headache%22">Headache</searchLink><br /><searchLink fieldCode="DE" term="%22Adverse+health+care+events%22">Adverse health care events</searchLink><br /><searchLink fieldCode="DE" term="%22Spasms%22">Spasms</searchLink><br /><searchLink fieldCode="DE" term="%22Drowsiness%22">Drowsiness</searchLink>
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  Data: 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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  Data: <i>Copyright of Acta Neurologica Scandinavica is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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