Safety and tolerability of perampanel: a review of clinical trial data
Article first published online: 11 MAR 2013
© 2013 John Wiley & Sons A/S
Acta Neurologica Scandinavica
Special Issue: Perampanel. Publication of this supplement was supported by Eisai.
Volume 127, Issue Supplement s197, pages 30–35, April 2013
How to Cite
Safety and tolerability of perampanel: a review of clinical trial data. Acta Neurol Scand: 2013: 127 (Suppl. 197): 30–35. © 2013 John Wiley & Sons A/S., , , .
- Issue published online: 11 MAR 2013
- Article first published online: 11 MAR 2013
- Manuscript Accepted: 4 JAN 2013
- Eisai Inc
- clinical trials;
- partial seizures;
The Phase II and Phase III clinical development program of perampanel is providing a wealth of data on the safety and tolerability of this alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist as an adjuvant treatment for refractory partial-onset seizures. In Phase II dose-finding studies, perampanel was associated with an acceptable tolerability profile up to the maximum evaluated dose of 12 mg/day. Subsequent multinational, multicenter, randomized, double-blind, placebo-controlled Phase III registration studies further supported the tolerability of perampanel across the dose range 2–12 mg/day, with interim data from ongoing extension studies indicating that safety outcomes may be maintained over several years. An analysis of the pooled Phase III data indicated that the frequency of adverse events reported with perampanel generally increased in a dose-dependent manner, and the most common adverse events were dizziness and somnolence. Overall, perampanel has been associated with an acceptable and consistent safety profile that is maintained over long-term settings.