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%]

Responder rate was defined as percentage of patients with a ≥50% reduction in seizure frequency from baseline. Percentages of responders and 95% CIs are based on the number of patients with post-baseline seizure data.

EFF = efficacy; ESL = eslicarbazepine acetate; SSF = standardized seizure frequency (seizure frequency is standardized to a 28-day frequency); SD = standard deviation; CI = confidence interval; AED = antiepileptic drug.