Table 1.
Efficacy data from phase II and phase III studies [Ben-Menachem et al. 2007; Halasz et al. 2009; Chung et al. 2010b] ITT population, ranges (min–max).
| Reference | Study no. | Phase | Design | Study population, years | Study duration, weeks | Median seizure reduction, % | 50% responder rate, % | Seizure freedom, % |
|---|---|---|---|---|---|---|---|---|
| Ben-Menachem et al. [2007] | SP667 | IIb | r, db, pc | 418 (18–65) | 28 (8 b + 6 ti + 12 m + 2 tr) | placebo: 10 | placebo: 21.9 | placebo: 0 |
| 200 mg: 26 (p = 0.1010) | 200 mg: 32.7 (p = 0.0899) | 200 mg: 0.9 | ||||||
| 400 mg: 39 (p = 0.0023) | 400 mg: 41.1 (p = 0.0038) | 400 mg: 4.6 | ||||||
| 600 mg: 40 (p = 0.0084) | 600 mg: 38.1 (p = 0.0141) | 600 mg: 0.9 | ||||||
| Chung et al. [2010b] | SP754 | III | r, db, pc | 405 (16–70) | 28 (8 b + 6 ti + 12 m + 2 tr) | placebo: 20.8 | placebo: 18.3 | placebo: 0 |
| 400 mg: 37.3 (p = 0.008) | 400 mg: 38.3 (p < 0.001) | 400 mg: 2.5 | ||||||
| 600 mg: 37.8 (p = 0.006) | 600 mg: 41.2 (p < 0.001) | 600 mg: 8.1 | ||||||
| Halasz et al. [2009] | SP755 | III | r, db, pc | 485 (16–70) | 26 (8 b + 4 t + 12 m + 2 ti) | placebo: 20.5 | placebo: 25.8 | placebo: 2.1 |
| 200 mg: 35.3 (p = 0.02) | 200 mg: 35.0 (p = 0.07) | 200 mg: 3.6 | ||||||
| 400 mg: 36.4 (p = 0.03) | 400 mg: 40.5 (p = 0.01) | 400 mg: 2.4 |
Statistically significant results are shown in bold.
b, baseline period; db, double blind; ITT, intention-to-treat; m, maintenance period; pc, placebo-controlled; r, randomized; ti, titration period; tr, transition period.