AES Highlights: Resnick on Study 307

Trevor Resnick, MD: This is a [follow-up] from what we had previously discussed with perampanel’s effectiveness for generalized seizures. In this [E2007-G000-307] study, what they had found was that the seizure freedom rate in those patients who were on perampanel for adjunctive therapy was very robust. But 1 of the criticisms would be, well, it’s only a 12-week maintenance phase. How do we know that it continues to work afterward? And what was done in this post hoc analysis of these patients in the open-label extension part of the study was to say, well, of those patients who were seizure-free during this 12-week maintenance period, when they entered the open-label extension, how many of them stayed seizure-free?

And what was gratifying was the fact that I think around 90% of them—even 6 months after entry into the open-label extension—maintained their seizure freedom. And then the numbers dropped a little bit afterward. But often, the reason the numbers dropped as you went to 1 year, 2 years, and 3 years out was because many of the studies were closed out so they couldn’t continue with the open-label extension. But even if you get to 6 months or a year having a 75% or 90% sustained seizure freedom indicates that that data from the controlled study was sustained afterward in the open-label extension.

Yeah. I think it’s very difficult to do a longer, longer study. And so they want to do a study that they believe is clinically meaningful over, say, a 3-month period. And if it is, the data [are] published, and then if you want to look at questions such as sustainability of seizure freedom, that’s when you do an open-label extension.