Table 5.
Simulated cumulative percentage of seizure-free patients at each dose step
| Subset | Dosing scenarioa | Percentage seizure free (90% CI)b | ||
|---|---|---|---|---|
| Dose step 1 | Dose step 2 | Dose step 3 | ||
| All patients | (A) As in SP0993 | 54.4 (49.4–59.1) | 63.7 (59.4–68.4) | 68.4 (64.1–73.4) |
| (B) NSP3M-based | 56.7 (51.7–61.4) | 66.1 (61.6–70.9) | 70.2 (65.7–74.7) | |
| Subset with NSP3M ≥7 | (A) As in SP0993 | 30.5 (21.9–39.0) | 41 (31.4–49.5) | 49.5 (40.0–59.0) |
| (B) NSP3M-based | 40 (28.6–52.4) | 52.4 (41.0–61.9) | 57.1 (46.7–65.7) | |
CI confidence interval, LCM lacosamide, NSP3M number of seizures in the 3 months before the trial
aDefault dosing scheme of LCM as in SP0993 is compared with a regimen with a higher initial target dose for patients with NSP3M ≥7
b5th–95th percentiles of 500 bootstrap replicates