TABLE 1.
Incidence of treatment‐emergent adverse events during the titration phase in the pooled DB period and study C021
| C013 | C017 | Pooled DB | Study C021 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| CNB 200 mg/day | PBO | CNB 100 mg/day | CNB 200 mg/day | CNB 400 mg/day | PBO | Cenobamate | Placebo | Cenobamate | |
| n, % | n = 113 | n = 109 | n = 108 | n = 110 | n = 111 | n = 107 | n = 442 | n = 216 | n = 1340 |
| Subjects with ≥1 TEAE | 74 (65.5) | 57 (52.3) | 57 (52.8) | 69 (62.7) | 96 (86.5) | 61 (57.0) | 296 (67.0) | 118 (54.6) | 960 (71.6) |
| Mild | 36 (31.9) | 32 (29.4) | 31 (28.7) | 37 (33.6) | 35 (31.5) | 41 (38.3) | 139 (31.4) | 73 (33.8) | 589 (44.0) |
| Moderate | 37 (32.7) | 21 (19.3) | 21 (19.4) | 24 (21.8) | 46 (41.4) | 16 (15.0) | 128 (29.0) | 37 (17.1) | 324 (24.2) |
| Severe | 1 (0.9) | 4 (3.7) | 5 (4.6) | 8 (7.3) | 15 (13.5) | 4 (3.7) | 29 (6.6) | 8 (3.7) | 47 (3.5) |
| TEAEs ≥5% | |||||||||
| Nervous system disorders | 44 (38.9) | 34 (31.2) | 41 (38.0) | 46 (41.8) | 73 (65.8) | 27 (25.2) | 204 (46.2) | 61 (28.2) | 612 (45.7) |
| Somnolence | 20 (17.7) | 7 (6.4) | 15 (13.9) | 19 (17.3) | 40 (36.0) | 7 (6.5) | 94 (21.3) | 14 (6.5) | 295 (22.0) |
| Dizziness | 22 (19.5) | 14 (12.8) | 15 (13.9) | 18 (16.4) | 32 (28.8) | 11 (10.3) | 87 (19.7) | 25 (11.6) | 222 (16.6) |
| Headache | 8 (7.1) | 11 (10.1) | 5 (4.6) | 7 (6.4) | 8 (7.2) | 6 (5.6) | 28 (6.3) | 17 (7.9) | 101 (7.5) |
| Discontinuation during titration due to TEAEs, n (%) | |||||||||
| 4 (3.5) | 4 (3.7) | 5 (4.6) | 11 (10.0) | 20 (18.0) | 1 (0.9) | 40 (9.0) | 5 (2.3) | 102 (7.6) | |
| TEAEs leading to study discontinuation, ≥2% | |||||||||
| Ataxia | 0 | 1 (0.9) | 0 | 3 (2.7) | 4 (3.6) | 0 | 7 (1.6) | 1 (0.5) | 3 (0.2) |
| Somnolence | 0 | 1 (0.9) | 0 | 2 (1.8) | 3 (2.7) | 0 | 5 (1.1) | 1 (0.5) | 6 (0.4) |
| Dizziness | 0 | 0 | 0 | 0 | 4 (3.6) | 0 | 4 (0.9) | 0 | 10 (0.7) |
| Nystagmus | 0 | 0 | 0 | 1 (0.9) | 3 (2.7) | 0 | 4 (0.9) | 0 | 0 |