Publication details

Tolerability and safety of perampanel: two randomized dose-escalation studies

Authors

KRAUSS G.L. BAR M. BITON V. KLAPPER J.A. REKTOR Ivan VAICIENE-MAGISTRIS N. SQUILLACOTE D. GUPTA Dwijendra Kumar

Year of publication 2012
Type Article in Periodical
Magazine / Source Acta Neurologica Scandinavica
MU Faculty or unit

Faculty of Medicine

Citation
Doi http://dx.doi.org/10.1111/j.1600-0404.2011.01588.x
Field Neurology, neurosurgery, neurosciences
Keywords antiepileptic drugs; efficacy; partial-onset; perampanel; refractory; safety
Attached files
Description Objectives - To evaluate, for the first time in patients with epilepsy, the tolerability and safety of escalating doses of oral perampanel, a novel, selective, non-competitive AMPA antagonist, as adjunctive therapy for refractory partial-onset seizures. Materials and methods - Two consecutive, randomized, double-blind, dose-escalation studies recruited adults (18-70 years) with uncontrolled partial-onset seizures receiving one to three concomitant antiepileptic drugs. In study 206, patients were treated for 12 weeks (8-week dose-titration, 4-week dose-maintenance) with placebo or perampanel (up to 4 mg/day, dosed once-or twice-daily). In study 208, patients received placebo or perampanel once-daily (up to 12 mg) for 16 weeks (12-week titration, 4-week maintenance). Results - Overall, 153 patients were randomized into study 206 (perampanel twice-daily, n = 51; perampanel once-daily, n = 51; placebo, n = 51). Study 208 included 48 patients (perampanel once-daily, n = 38; placebo, n = 10). The highest dose in study 206 - 4 mg/day - was well tolerated, with similar proportions of patients tolerating once-daily (82.4%) and twice-daily (82.4%) perampanel and placebo (82.4%) treatments. In study 208 most patients tolerated doses of 6 mg perampanel once-daily in a Kaplan-Meier analysis. In both studies, the most common adverse events were CNS-related; most were of mild/moderate severity. Conclusions Perampanel was well tolerated across doses of 4-12 mg/day. The studies showed preliminary evidence of efficacy and identified doses to be evaluated in larger clinical studies.

You are running an old browser version. We recommend updating your browser to its latest version.

More info