Table 3 Number of different seizure types and average seizure rate per animal
High dose (30 mg/kg) | Low dose (1 mg/kg) High dose in Phase 2 | Significancea, high dose vs. low dose group | ||
|---|---|---|---|---|
Seizure type | Total number (rate) | Total number (rate) | ||
Phase 1: Primary Efficacy Evaluation | Number of animals in phase 1 | N = 64 | N = 60 | |
Generalized tonic-clonic seizures | 73 (1.14) | 95 (1.58) | p = 0.035 | |
Cluster seizures | 17 (0.27) | 9 (0.15) | p = 0.156 | |
Partial or complex partial seizures | 30 (0.47) | 75 (1.25) | p < 0.001 | |
Total during part 1 | 120 (1.88) | 179 (2.98) | p < 0.001 | |
Phase 2: Extended use at high dose | Number of animals in phase 2 | N = 53 | N = 47 | |
Generalized tonic-clonic | 60 (1.13) p = 0.966b | 45 (0.96) p = 0.004b | p = 0.393 | |
Cluster seizures, convulsive status | 21 (0.40) p = 0.226b | 9 (0.19) p = 0.609b | p = 0.057 | |
Partial or complex partial seizures | 5 (0.09) p < 0.001b | 19 (0.40) p < 0.001b | p = 0.002 | |
Total during phase 2 | 86 (1.62) p = 0.303b vs. phase 1 | 73 (1.55) p = 0.001b | p = 0.783 |