Publication details
Perampanel Study 207: long-term open-label evaluation in patients with epilepsy
| Authors | |
|---|---|
| Year of publication | 2012 |
| Type | Article in Periodical |
| Magazine / Source | Acta Neurologica Scandinavica |
| MU Faculty or unit | |
| Citation | |
| Web | http://onlinelibrary.wiley.com/doi/10.1111/ane.12001/abstract |
| Doi | http://dx.doi.org/10.1111/ane.12001 |
| Field | Neurology, neurosurgery, neurosciences |
| Keywords | a-amino-3-hydroxy-5-methyl-5-isoxazolepropionic acid; antiepileptic drugs; epilepsy; glutamate; long-term safety; open-label extension; perampanel; post-synaptic |
| Attached files | |
| Description | 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. |