Table 4 Percentage change from baseline in standardized seizure frequency during the monotherapy and double-blind periods, and responder rate by study period (EFF population)
Study period | ESL 1200 mg (n = 54) | ESL 1600 mg (n = 100) |
|---|---|---|
% change in SSF from baseline for the 10-week monotherapy period | ||
Mean ± SD | −42.3 ± 42.48 | −39.2 ± 57.93 |
Median | −45.7 | −52.1 |
% change in SFF from baseline for the 18-week double-blind period | ||
Mean ± SD | −33.0 ± 43.33 | −37.3 ± 46.26 |
Median | −36.1 | −47.5 |
Responder rate | ||
Titration period; n (%) [95% CI] | 16 (29.6%) [18.0–43.6%] | 37 (37.0%) [27.6–47.2%] |
AED conversion period; n (%) [95% CI] | 16 (29.6%) [18.0–43.6%] | 39 (39.0%) [29.4–49.3%] |
Monotherapy period; n (%) [95% CI] | 21 (38.9%) [29.5–58.8%] | 46 (46.0%) [41.4–63.0%] |
Double-blind period; n (%) [95% CI] | 19 (35.2%) [22.7–49.4%] | 46 (46.0%) [36.0–56.3%] |