Perampanel: Phase III data

Researchers at New York University's Comprehensive Epilepsy Center and colleagues reported data from an international Phase III trial of perampanel as an adjunctive therapy for partial seizures in patients with epilepsy. In the full intent-to-treat (ITT) population (n=387), which consisted of all treated patients with any post-baseline seizure data, 8 and 12 mg perampanel met the primary endpoint of significantly reducing median seizure frequency per 28 days during the 19-week double-blind treatment period (6-week titration phase followed by a 13-week maintenance period) vs. placebo (26.3% and 34.5%, respectively vs. 21%; p=0.0261 and p=0.0158). In the ITT population (n=381), which consisted of all treated patients with >=2 weeks of post-baseline seizure data, high-dose perampanel met the primary endpoint vs. placebo (39.5% vs. 22.9%, p=0.0304), but the low dose did not (32.1%, p=0.0812).

Additionally, the placebo rates in the full ITT and ITT populations were lower for patients enrolled in North American trial sites (11.3% and 12.1%, respectively) vs. patients enrolled in Latin America trial sites (26.2% and 33.1%, respectively). The researchers said the difference is likely related to poor patient selection in Latin America. As a result, both doses of perampanel significantly reduced median seizure frequency in North American patients vs. placebo, but not in Latin American patients. Furthermore, both doses of perampanel met the secondary endpoint of significantly reducing median frequency of complex partial plus secondarily generalized seizures vs. placebo in the full ITT population (33% and 33.1%, respectively, vs. 17.9%; p=0.002 and p=0.008). ...