The SAS included 241 South Korean patients (placebo, n=65; perampanel, n=176); the FAS included 225 patients (placebo, n=64; perampanel, n=161). Across double-blind studies, median reductions in seizure frequency/28 days (placebo vs perampanel) were 16.1% vs 25.8% (POS), -16.6% vs 55.6% (SGS), and -54.8% vs 72.3% (PGTCS). Corresponding 50% responder rates were 20.0% (n=12/60) vs 32.9% (n=52/158), 20.0% (n=2/10) vs 59.5% (n=25/42), and 0.0% (n=0/4) vs 66.7% (n=2/3) for POS, SGS, and PGTCS, respectively; seizure-freedom rates were 1.7% (n=1/60) vs 1.3% (n=2/158), 10.0% (n=1/10) vs 26.2% (n=11/42), and 0.0% (n=0/3) vs 33.3% (n=1/3), respectively.
Across double-blind studies, TEAEs occurred in 47 (72.3%) placebo-treated and 144 (81.8%) perampanel-treated patients; with perampanel, the most common were dizziness (n=75 [42.6%]) and somnolence (n=42 [23.9%]).
Overall, 215 patients entered the OLEx studies (POS, n=210; SGS, n=60; PGTCS, n=5); median reductions in seizure frequency/28 days during Year 1 were: POS, 18.4%; SGS, 55.8%; PGTCS, 84.0%. TEAEs occurred in 52/215 (24.2%) patients.