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Interictal High Frequency Oscillations Detected with Simultaneous Magnetoencephalography and Electroencephalography as Biomarker of Pediatric Epilepsy

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

I Rektor¹, G L Krauss, M Bar

¹Brno Epilepsy Centre, First Department of Neurology, St Anne's University Hospital, Masaryk University, Brno, Czech Republic. irektor@med.muni.cz

Acta Neurologica Scandinavica

|August 24, 2012

Summary

Long-term adjunctive perampanel treatment up to 4 years demonstrated good tolerability and safety in patients with refractory partial-onset seizures. Efficacy, including seizure control, was maintained throughout the extended treatment period.

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Area of Science:

Neurology
Pharmacology

Background:

Refractory partial-onset seizures pose a significant treatment challenge.
Perampanel, an AMPA-receptor antagonist, offers a novel therapeutic approach.

Purpose of the Study:

To evaluate the long-term tolerability, safety, and efficacy of adjunctive perampanel.
Assess outcomes in patients with refractory partial-onset seizures over an extended treatment duration.

Main Methods:

An open-label extension study (Study 207) enrolled patients completing Phase II trials.
Patients received perampanel titrated up to 12 mg/day, with treatment continuing for up to approximately 8 years.
Interim analysis data were collected up to December 1, 2010.

Main Results:

Over a third of patients (38.4%) remained on perampanel at the 4-year interim analysis.
No new safety signals were identified with long-term perampanel use.
A median reduction of 31.5% in seizure frequency was observed during open-label treatment.

Conclusions:

Adjunctive perampanel exhibits a favorable tolerability profile for long-term use in refractory partial-onset seizures.
Sustained seizure control improvements were observed with extended perampanel treatment.