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