Active Ingredient: PERAMPANEL
In a thorough QT study of 261 healthy subjects and a pooled analysis of 1,480 patients from Phase III trials, doses up to 12 mg/day were evaluated. The maximum mean placebo-corrected QTcF change (ΔΔQTcF) was only 3.92 ms, with the upper 95% confidence interval consistently below the 10 ms regulatory threshold. No concentration-QT relationship was observed, and no dose-dependent increases in QTc intervals were found in the patient population.
https://doi.org/10.1016/j.eplepsyres.2015.04.010