Table 2.
Summary of phase III randomized, double-blind, placebo-controlled studies for add-on therapy of lacosamide (LCM) in patients with partial epilepsy
| Study | SP667 | SP755 | SP754 |
|---|---|---|---|
| Published as | original report (Ben-Menachem et al26) |
original report (Halasz et al28) |
poster (Chung et al36) |
| Number of subjects randomized | 421 | 485 | 405 |
| Time-scale | 8 weeks prospective baseline 6 weeks titration 12 weeks maintenance | 8 weeks prospective baseline 4 weeks titration 12 weeks maintenance | 8 weeks prospective baseline 6 weeks titration 12 weeks maintenance |
| Study arms | Placebo | Placebo | Placebo |
| LCM 200 mg/day | LCM 200 mg/day | LCM 400 mg/day | |
| LCM 400 mg/day | LCM 400 mg/day | LCM 600 mg/day | |
| LCM 600 mg/day | |||
| Randomization scheme | placebo, 200 mg, 400 mg, 600 mg 1:1:1:1 | placebo, 200 mg, 400 mg 1:1:1 | placebo, 400 mg, 600 mg 1:2:1 |
| Number of subjects in ITT population | 415 | 477 | 402 |
| placebo, 200 mg, 400 mg, 600 mg: 96, 107, 107, 105 | placebo, 200 mg, 400 mg: 159, 160, 158 | placebo, 400 mg, 600 mg: 104, 201, 97 | |
| Number of subjects completed | 312 | 399 | no data |
| placebo, 200 mg, 400 mg, 600 mg: 86, 85, 80 ,61 | placebo, 200 mg, 400 mg: 141, 136, 122 | ||
| Number of subjects discontinued | 11, 22, 28, 45 (11%, 21%, 26%, 43%) | 22, 27, 37 (14%, 20%, 23%) | no data |
| Discontinued because of adverse events | 5, 16, 20 ,32 | 9, 10, 25 | placebo, 400 mg, 600 mg 5%, 18%, 27% |
Abbreviation: ITT, intention-to-treat.