Table 1. Patient Baseline Demographic Characteristics.
| Characteristic | Patients, No. (%) | ||||
|---|---|---|---|---|---|
| Placebo (n = 114) | XEN1101, 10 mg (n = 46) | XEN1101, 20 mg (n = 51) | XEN1101, 25 mg (n = 114) | Total (N = 325) | |
| Age, mean (SD), y | 42.9 (13.7) | 40.0 (12.1) | 41.7 (13.6) | 38.7 (13.1) | 40.8 (13.3) |
| Age at study entry category | |||||
| ≥65 y | 5 (4.4) | 2 (4.3) | 4 (7.8) | 1 (0.9) | 12 (3.7) |
| <65 y | 109 (95.6) | 44 (95.7) | 47 (92.2) | 113 (99.1) | 313 (96.3) |
| Sex | |||||
| Female | 61 (53.5) | 27 (58.7) | 26 (51.0) | 54 (47.4) | 168 (51.7) |
| Male | 53 (46.5) | 19 (41.3) | 25 (49.0) | 60 (52.6) | 157 (48.3) |
| Region | |||||
| Europe | 67 (58.8) | 31 (67.4) | 32 (62.7) | 68 (59.6) | 198 (60.9) |
| North America | 47 (41.2) | 15 (32.6) | 19 (37.3) | 46 (40.4) | 127 (39.1) |
| BMI, mean (SD) | 27.3 (5.4) | 26.6 (5.1) | 26.7 (5.0) | 26.5 (5.1) | 26.8 (5.2) |
| Age at disease onset, mean (SD), y | 19.2 (14.7) | 19.8 (14.8) | 14.1 (12.1) | 15.3 (12.1) | 17.1 (13.6) |
| CYP3A4 inducer use | |||||
| No | 45 (39.5) | 21 (45.7) | 22 (43.1) | 49 (43.0) | 137 (42.2) |
| Yes | 69 (60.5) | 25 (54.3) | 29 (56.9) | 65 (57.0) | 188 (57.8) |
| Background ASM use | |||||
| 1 | 12 (10.5) | 4 (8.7) | 2 (3.9) | 11 (9.6) | 29 (8.9) |
| 2 | 46 (40.4) | 18 (39.1) | 20 (39.2) | 48 (42.1) | 132 (40.6) |
| 3 | 56 (49.1) | 24 (52.2) | 29 (56.9) | 55 (48.2) | 164 (50.5) |
| No. of prestudy ASMs failed, median (IQR) | 6.0 (4.0-8.0) | 5.0 (4.0-9.0) | 6.0 (4.0-9.0) | 6.0 (3.0-9.0) | 6.0 (4.0-9.0) |
Abbreviations: ASM, antiseizure medication; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).