TABLE 1.
Baseline demographics and epilepsy characteristics by number of concomitant ASMs (safety set)
| Characteristic | One concomitant ASM | Two concomitant ASMs | ||||
|---|---|---|---|---|---|---|
| Placebo, n = 95 | BRV 50–200 mg/day, n = 181 | All patients, n = 276 | Placebo, n = 331 | BRV 50–200 mg/day, n = 557 | All patients, n = 888 | |
| Age, years, mean (SD) | 39.0 (14.4) | 42.0 (14.7) | 41.0 (14.7) | 38.1 (12.2) | 38.0 (12.4) | 38.1 (12.3) |
| Male, n (%) | 43 (45.3) | 83 (45.9) | 126 (45.7) | 170 (51.4) | 283 (50.8) | 453 (51.0) |
| Duration of epilepsy, years, mean (SD) | 19.2 (13.3) | 20.8 (14.3) | 20.2 (14.0) | 23.7 (12.5) | 23.8 (13.1) | 23.7 (12.9) |
| Age at onset of epilepsy, years, mean (SD) | 20.5 (14.8) | 21.8 (16.2) | 21.3 (15.7) | 15.1 (12.1) | 14.9 (11.9) | 14.9 (12.0) |
| Baseline focal seizure frequency per 28 days, median (Q1, Q3) | 8.0 (5.0, 16.0) | 8.5 (5.7, 15.1) | 8.5 (5.5, 15.3) | 10.1 (5.9, 24.3) | 8.9 (5.5, 20.0) | 9.3 (5.5, 22.3) |
| Prior ASMs, median n (range) a | 2.0 (0–12.0) | 2.0 (0–17.0) | 2.0 (0–17.0) | 3.0 (0–15.0) | 3.0 (0–13.0) | 3.0 (0–15.0) |
| Prior ASMs, n (%) a | ||||||
| 0–1 | 36 (37.9) | 70 (38.7) | 106 (38.4) | 86 (26.0) | 153 (27.5) | 239 (26.9) |
| 2–4 | 37 (38.9) | 59 (32.6) | 96 (34.8) | 140 (42.3) | 222 (39.9) | 362 (40.8) |
| ≥5 | 22 (23.2) | 52 (28.7) | 74 (26.8) | 105 (31.7) | 182 (32.7) | 287 (32.3) |
| Prior LEV treatment, n (%) | 33 (34.7) | 71 (39.2) | 104 (37.7) | 143 (43.2) | 236 (42.4) | 379 (42.7) |
Abbreviations: ASM, antiseizure medication; BRV, brivaracetam; LEV, levetiracetam; Q1, 25th percentile; Q3, 75th percentile.
a
Prior ASMs were ASMs discontinued before trial drug initiation. Trials N01252 and N01253 collected ASM use within the 5 years before trial entry, whereas trial N01358 collected all history of ASMs used before trial entry.