Figure 2:

A hypothetical illustration of how the estimate of seizure frequency (seizure freq) stabilizes over the course of the typical 12-week randomized controlled trial (RCT) for a simulated participant randomized to placebo who had 6 seizures (Sz) in a 4-week baseline. The simulation was using the methods of Goldenholz and colleagues (Ann Clin Trans Neurol 2017). The time-to-event endpoint of time-to-prerandomization monthly seizure count (T-PSC) is illustrated at 48 days, with an interim seizure frequency reduction of 44%, compared to a 56% reduction when treatment was continued through 12-weeks. Comparison to other historical escape criteria is illustrated by highlighting seizure clusters.