TABLE 1.
Indian and non‐Indian patient demographics and baseline characteristics during the double‐blind and OLEx studies (Safety Analysis Set)
| Double‐blind studies | OLEx studies | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Perampanel | Perampanel | |||||
| 2 mg/day | 4 mg/day | 8 mg/day | 12 mg/day | Total | |||
| Indian patients | |||||||
| n | 39 | 12 | 9 | 54 | 14 | 89 | 110 |
| Mean age, y (SD) | 22.0 (8.9) | 24.8 (8.5) | 29.3 (6.8) | 20.2 (8.3) | 29.7 (11.2) | 23.2 (9.5) | 23.1 (9.2) |
| Female, n (%) | 10 (25.6) | 8 (66.7) | 2 (22.2) | 21 (38.9) | 6 (42.9) | 37 (41.6) | 41 (37.3) |
| Median BMI, kg/m2 (min, max) | 20.6 (14.2, 33.8) | 18.6 (16.4, 25.7) | 21.6 (17.5, 28.5) | 18.4 (15.4, 33.6) | 21.5 (15.9, 36.7) | 19.2 (15.4, 36.7) | 20.1 (14.2, 33.8) |
| Seizure type, n (%) | |||||||
| Focal aware without motor signs | 2 (5.1) | 1 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.1) | 3 (2.7) |
| Focal aware with motor signs | 11 (28.2) | 4 (33.3) | 2 (22.2) | 7 (13.0) | 3 (21.4) | 16 (18.0) | 23 (20.9) |
| Focal impaired awareness | 17 (43.6) | 9 (75.0) | 5 (55.6) | 33 (61.1) | 8 (57.1) | 55 (61.8) | 62 (56.4) |
| Focal with FBTCS | 15 (38.5) | 1 (8.3) | 4 (44.4) | 11 (20.4) | 5 (35.7) | 21 (23.6) | 29 (26.4) |
| Tonic‐clonic | 6 (15.4) | 0 (0.0) | 0 (0.0) | 7 (13.0) | 0 (0.0) | 7 (7.9) | 11 (10.0) |
| Myoclonic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 1 (1.1) | 1 (0.9) |
| Absence | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0 | 0 (0.0) |
| Non‐Indian patients | |||||||
| n | 709 | 168 | 339 | 718 | 421 | 1646 | 2037 |
| Mean age, y (SD) | 33.1 (13.8) | 34.5 (13.7) | 33.5 (12.8) | 32.8 (14.3) | 34.7 (13.7) | 33.6 (13.8) | 33.0 (13.6) |
| Female, n (%) | 368 (51.9) | 87 (51.8) | 176 (51.9) | 366 (51.0) | 223 (53.0) | 852 (51.8) | 38 (51.0) |
| Median BMI, kg/m2 (min, max) | 23.5 (12.3, 50.5) | 23.6 (16.4, 41.7) | 23.4 (11.9, 39.6) | 23.7 (14.1, 47.4) | 23.5 (11.1, 45.7) | 23.6 (11.1, 47.4) | 23.4 (11.1, 50.5) |
| Seizure type, n (%) | |||||||
| Focal aware without motor signs | 137 (19.3) | 34 (20.2) | 62 (18.3) | 151 (21.0) | 85 (20.2) | 332 (20.2) | 388 (19.0) |
| Focal aware with motor signs | 157 (22.1) | 41 (24.4) | 100 (29.5) | 176 (24.5) | 98 (23.3) | 415 (25.2) | 492 (24.2) |
| Focal impaired awareness | 517 (72.9) | 133 (79.2) | 259 (76.4) | 497 (69.2) | 338 (80.3) | 227 (74.5) | 513 (74.3) |
| Focal with FBTCS | 232 (32.7) | 67 (39.9) | 125 (36.9) | 229 (31.9) | 158 (37.5) | 579 (35.2) | 709 (34.8) |
| Tonic‐clonic | 76 (10.7) | 0 (0.0) | 0 (0.0) | 74 (10.3) | 0 (0.0) | 74 (4.5) | 127 (6.2) |
| Myoclonic | 24 (3.4) | 0 (0.0) | 0 (0.0) | 23 (3.2) | 0 (0.0) | 23 (1.4) | 43 (2.1) |
| Absence | 33 (4.7) | 0 (0.0) | 0 (0.0) | 27 (3.8) | 0 (0.0) | 27 (1.6) | 50 (2.5) |
| Tonic | 2 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.1) |
| Atonic | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Abbreviations: BMI, body mass index; FBTCS, focal to bilateral tonic‐clonic seizures; max, maximum; min, minimum; OLEx, open‐label extension; SD, standard deviation.