Table 3 Summary of primary outcome endpoints which are applicable to clinical studies and highlight different aspects of outcome; modified from [65, 66, 73]
Outcome parameters | |
|---|---|
Efficacy | |
 Conventional endpoints | fixed treatment period |
 Seizure free rate (percentage seizure freedom)a | no baseline data required |
  Short-term | 24 weeks |
  Long-term | 48 weeks – 3 years |
 Median seizure frequency reduction | baseline data required |
 Responder rate (percentage responders) | baseline data required |
(≥50 % reduction median seizure frequency often not clinically relevant) | |
 Individual endpoints | |
 Time to first seizure | based on interseizure interval |
 Time to second seizure |  |
 Time to n-th seizure |  |
 Pre-defined patient-centered outcome criteria | individually assessed |
Tolerability | |
 Adverse events | to be assessed, also assess number and reasons for drop-outs |
Quality of life | |
 Patient’s QOL score | validated scores needed |
 Owner’s QOL score | control groups important |
Retention rate | applicable to long-term studies |