Table 1.
Summary of Phase III efficacy trials of perampanel as adjunctive therapy for partial seizures
| Study | Number of subjects | Median percent change in seizure frequency from baseline (significance vs placebo) | Responder rate | Seizure freedom |
|---|---|---|---|---|
| 30419 | 387 | Placebo =21%, 8 mg/day =26.3% (p=0.026), 12 mg/day =34.5% (p=0.016) |
Placebo =26.4%, 8 mg/day =37.6% (p=0.076),a 12 mg/day =36.1% (p=0.091)a |
Placebo =0%, 8 mg/day =2.2%, 12 mg/day =1.5% |
| 30520 | 386 | Placebo =9.7%, 8 mg/day =30.5% (p<0.001), 12 mg/day =17.6% (p=0.011) |
Placebo =14.7%, 8 mg/day =33.3% (p=0.002), 12 mg/day =33.9% (p<0.001) |
Placebo =1.5%, 8 mg/day =2.3%, 12 mg/day =5% |
| 30621 | 705 | Placebo =10.7%, 2 mg/day =13.6% (NS), 4 mg/day =23.3% (p=0.0026), 8 mg/day =30.8% (p<0.0001) |
Placebo =17.9%, 2 mg/day =20.6% (NS), 4 mg/day =28.5% (p=0.0132), 8 mg/day =34.9% (p=0.0003) |
Placebo =1.2%, 2 mg/day =1.9%, 4 mg/day =4.4%, 8 mg/day =4.8% |
Note:
a
8 and 12 mg/day were both significant vs placebo (p<0.005) when considering North American data only.
Abbreviation: NS, non significant.