TABLE 2.
Baseline demographics and epilepsy characteristics by specific concomitant ASM in patients on one concomitant ASM (safety set)
| Characteristic | Patients on one concomitant ASM | |||||||
|---|---|---|---|---|---|---|---|---|
| Concomitant CBZ | Concomitant LTG | Concomitant OXC | Concomitant VPA | |||||
| Placebo, n = 34 | BRV 50–200 mg/day, n = 54 | Placebo, n = 13 | BRV 50–200 mg/day, n = 30 | Placebo, n = 10 | BRV 50–200 mg/day, n = 27 | Placebo, n = 15 | BRV 50–200 mg/day, n = 27 | |
| Age, years, mean (SD) | 39.1 (12.1) | 41.1 (13.3) | 34.1 (13.7) | 39.4 (15.8) | 40.3 (15.4) | 39.6 (17.5) | 36.9 (15.0) | 46.6 (14.1) |
| Male, n (%) | 17 (50.0) | 29 (53.7) | 3 (23.1) | 11 (36.7) | 3 (30.0) | 7 (25.9) | 12 (80.0) | 18 (66.7) |
| Duration of epilepsy, years, mean (SD) | 20.6 (11.8) | 21.6 (13.5) | 20.3 (12.9) | 19.5 (10.4) | 17.7 (19.1) | 18.6 (13.0) | 13.7 (8.0) | 22.0 (17.3) |
| Age at onset of epilepsy, years, mean (SD) | 19.2 (13.6) | 19.9 (14.5) | 14.3 (7.9) | 20.5 (16.3) | 23.2 (18.5) | 21.6 (16.6) | 23.9 (16.3) | 25.2 (20.3) |
| Baseline focal seizure frequency per 28 days, median (Q1, Q3) | 7.8 (5.1, 22.9) | 7.9 (5.3, 12.0) | 7.0 (5.7, 12.1) | 10.4 (6.5, 18.2) | 12.0 (8.7, 61.5) | 9.5 (5.5, 17.6) | 5.0 (4.0, 12.0) | 9.3 (6.5, 22.0) |
| Prior ASMs, median n (range) a | 1.5 (0–11) | 1.5 (0–17.0) | 3.0 (1.0–10.0) | 4.0 (0–14.0) | 3.0 (0–12.0) | 3.0 (0–11.0) | 2.0 (0–7.0) | 1.0 (0–9.0) |
| Prior ASMs, n (%) a | ||||||||
| 0–1 | 17 (50.0) | 27 (50.0) | 3 (23.1) | 6 (20.0) | 3 (30.0) | 9 (33.3) | 6 (40.0) | 14 (51.9) |
| 2–4 | 10 (29.4) | 17 (31.5) | 6 (46.2) | 13 (43.3) | 4 (40.0) | 8 (29.6) | 7 (46.7) | 8 (29.6) |
| ≥5 | 7 (20.6) | 10 (18.5) | 4 (30.8) | 11 (36.7) | 3 (30.0) | 10 (37.0) | 2 (13.3) | 5 (18.5) |
| Prior LEV treatment, n (%) | 9 (26.5) | 17 (31.5) | 9 (69.2) | 15 (50.0) | 3 (30.0) | 13 (48.1) | 3 (20.0) | 7 (25.9) |
Abbreviations: ASM, antiseizure medication; BRV, brivaracetam; CBZ, carbamazepine; LEV, levetiracetam; LTG, lamotrigine; OXC, oxcarbazepine; Q1, 25th percentile; Q3, 75th percentile; VPA, valproate.
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.