TABLE 3.
Trial EP0092 baseline demographics, epilepsy characteristics, lifetime and concomitant ASMs (full analysis set)
| Placebo (n = 54) | PSL 100 mg b.i.d. (n = 60) | PSL 200 mg b.i.d. (n = 56) | PSL 400 mg b.i.d. (n = 56) | All patients (n = 226) | |
|---|---|---|---|---|---|
| Patient demographics | |||||
| Age, mean (SD), years | 41.3 (13.3) | 40.7 (13.0) | 39.8 (14.3) | 39.8 (13.7) | 40.4 (13.5) |
| Female, n (%) | 32 (59.3) | 34 (56.7) | 28 (50.0) | 32 (57.1) | 126 (55.8) |
| Epilepsy characteristics | |||||
| Duration of epilepsy, mean (SD), years | 26.6 (13.7) | 21.8 (13.1) | 26.4 (13.8) | 23.1 (12.5) | 24.4 (13.3) |
| Age at onset of epilepsy, mean (SD), years | 15.5 (12.9) | 19.6 (13.3) | 14.1 (10.6) | 17.5 (14.4) | 16.7 (13.0) |
| VNS at screening, n (%) | 10 (18.5) | 9 (15.0) | 6 (10.7) | 13 (23.2) | 38 (16.8) |
| Evaluated for epilepsy surgery, n (%) | 26 (48.1) | 22 (36.7) | 18 (32.1) | 29 (51.8) | 95 (42.0) |
| Baseline focal seizure a frequency per 28 days, median (range) | 15.8 (3.6, 390.1) | 11.0 (3.7, 335.1) | 10.6 (3.0, 133.7) | 10.0 (3.6, 231.7) | 11.0 (3.0, 390.1) |
| Seizure classification history at any time before trial entry, n (%) | |||||
| Any focal seizures | 54 (100) | 60 (100) | 56 (100) | 56 (100) | 226 (100) |
| Focal aware | 21 (38.9) | 33 (55.0) | 27 (48.2) | 31 (55.4) | 112 (49.6) |
| With motor symptoms | 13 (24.1) | 21 (35.0) | 15 (26.8) | 19 (33.9) | 68 (30.1) |
| Focal impaired awareness | 46 (85.2) | 47 (78.3) | 48 (85.7) | 50 (89.3) | 191 (84.5) |
| Focal to bilateral tonic–clonic | 35 (64.8) | 38 (63.3) | 35 (62.5) | 34 (60.7) | 142 (62.8) |
| Any generalized seizures | 0 | 0 | 0 | 0 | 0 |
| Number of lifetime ASMs, median (range) b | |||||
| <4 | 2 (3.7) | 2 (3.3) | 4 (7.1) | 1 (1.8) | 9 (4.0) |
| 4–5 | 14 (25.9) | 19 (31.7) | 22 (39.3) | 9 (16.1) | 64 (28.3) |
| 6–7 | 13 (24.1) | 18 (30.0) | 15 (26.8) | 20 (35.7) | 66 (29.2) |
| 8–10 | 16 (29.6) | 13 (21.7) | 9 (16.1) | 13 (23.2) | 51 (22.6) |
| >10 | 9 (16.7) | 8 (13.3) | 6 (10.7) | 13 (23.2) | 36 (15.9) |
| Number of ASMs taken at trial entry, n (%) | |||||
| 1 | 2 (3.7) | 7 (11.7) | 7 (12.5) | 5 (8.9) | 21 (9.3) |
| 2 | 23 (42.6) | 21 (35.0) | 17 (30.4) | 28 (50.0) | 89 (39.4) |
| 3 | 25 (46.3) | 29 (48.3) | 29 (51.8) | 23 (41.1) | 106 (46.9) |
| >3 | 4 (7.4) | 3 (5.0) | 3 (5.4) | 0 | 10 (4.4) |
| Concomitant ASMs taken by ≥15% of all patients, n (%) | |||||
| Levetiracetam | 24 (44.4) | 21 (35.0) | 24 (42.9) | 23 (41.1) | 92 (40.7) |
| Lacosamide | 20 (37.0) | 24 (40.0) | 16 (28.6) | 19 (33.9) | 79 (35.0) |
| Lamotrigine | 18 (33.3) | 16 (26.7) | 21 (37.5) | 18 (32.1) | 73 (32.3) |
| Valproate sodium | 12 (22.2) | 17 (28.3) | 15 (26.8) | 11 (19.6) | 55 (24.3) |
| Oxcarbazepine | 14 (25.9) | 8 (13.3) | 13 (23.2) | 9 (16.1) | 44 (19.5) |
| Perampanel | 9 (16.7) | 4 (6.7) | 13 (23.2) | 10 (17.9) | 36 (15.9) |
| Topiramate | 8 (14.8) | 10 (16.7) | 5 (8.9) | 10 (17.9) | 33 (14.6) |
| Zonisamide | 6 (11.1) | 14 (23.3) | 6 (10.7) | 5 (8.9) | 31 (13.7) |
Abbreviations: ASM, antiseizure medication; b.i.d., twice daily; PSL, padsevonil; SD, standard deviation; VNS, vagus nerve stimulation.
a
Includes the following seizure types: focal aware with motor symptoms, focal impaired awareness, focal to bilateral tonic–clonic.
b
Includes previous ASMs and ASMs taken at trial entry.