TABLE 1.
Trial EP0091 baseline demographics, epilepsy characteristics, lifetime and concomitant ASMs (full analysis set)
| Placebo (n = 81) | PSL 50 mg b.i.d. (n = 80) | PSL 100 mg b.i.d. (n = 82) | PSL 200 mg b.i.d. (n = 81) | PSL 400 mg b.i.d. (n = 81) | All patients (n = 405) | |
|---|---|---|---|---|---|---|
| Patient demographics | ||||||
| Age, mean (SD), years | 39.8 (13.0) | 42.3 (11.5) | 36.7 (13.0) | 40.9 (12.0) | 38.9 (12.1) | 39.7 (12.4) |
| Female, n (%) | 48 (59.3) | 46 (57.5) | 47 (57.3) | 50 (61.7) | 43 (53.1) | 234 (57.8) |
| Epilepsy characteristics | ||||||
| Duration of epilepsy, mean (SD), years | 22.2 (13.1) | 25.8 (13.0) | 22.3 (12.4) | 24.7 (13.6) | 24.3 (12.0) | 23.9 (12.8) |
| Age at onset of epilepsy, mean (SD), years | 18.3 (13.1) | 17.4 (12.4) | 15.0 (11.5) | 17.0 (11.8) | 15.3 (11.8) | 16.6 (12.1) |
| VNS at screening, n (%) | 12 (14.8) | 15 (18.8) | 17 (20.7) | 15 (18.5) | 22 (27.2) | 81 (20.0) |
| Evaluated for epilepsy surgery, n (%) | 35 (43.2) | 47 (58.8) | 46 (56.1) | 28 (34.6) | 51 (63.0) | 207 (51.1) |
| Baseline focal seizure a frequency per 28 days, median (range) | 10.5 (3.3, 256.0) | 12.1 (3.7, 250.1) | 10.6 (1.0, 886.0) | 11.6 (3.2, 276.7) | 9.0 (3.2, 810.0) | 11.0 (1.0, 886.0) |
| Seizure classification history at any time before trial entry, n (%) | ||||||
| Any focal seizures | 81 (100) | 79 (98.8) | 82 (100) | 81 (100) | 81 (100) | 404 (99.8) |
| Focal aware | 27 (33.3) | 41 (51.3) | 39 (47.6) | 32 (39.5) | 42 (51.9) | 181 (44.7) |
| With motor symptoms | 13 (16.0) | 24 (30.0) | 22 (26.8) | 17 (21.0) | 19 (23.5) | 95 (23.5) |
| Focal impaired awareness | 67 (82.7) | 73 (91.3) | 74 (90.2) | 75 (92.6) | 67 (82.7) | 356 (87.9) |
| Focal to bilateral tonic–clonic | 50 (61.7) | 49 (61.3) | 47 (57.3) | 51 (63.0) | 49 (60.5) | 246 (60.7) |
| Any generalized seizures | 2 (2.5) | 5 (6.3) | 3 (3.7) | 2 (2.5) | 3 (3.7) | 15 (3.7) |
| Number of lifetime ASMs, n (%) b | ||||||
| <4 | 0 | 1 (1.3) | 0 | 2 (2.5) | 0 | 3 (0.7) |
| 4–5 | 20 (24.7) | 15 (18.8) | 24 (29.3) | 20 (24.7) | 19 (23.5) | 98 (24.2) |
| 6–7 | 16 (19.8) | 22 (27.5) | 18 (22.0) | 19 (23.5) | 18 (22.2) | 93 (23.0) |
| 8–10 | 27 (33.3) | 18 (22.5) | 19 (23.2) | 19 (23.5) | 25 (30.9) | 108 (26.7) |
| >10 | 18 (22.2) | 24 (30.0) | 21 (25.6) | 21 (25.9) | 19 (23.5) | 103 (25.4) |
| Number of ASMs taken at trial entry, n (%) | ||||||
| 1 | 9 (11.1) | 7 (8.8) | 7 (8.5) | 4 (4.9) | 7 (8.6) | 34 (8.4) |
| 2 | 36 (44.4) | 32 (40.0) | 33 (40.2) | 36 (44.4) | 36 (44.4) | 173 (42.7) |
| 3 | 34 (42.0) | 34 (42.5) | 41 (50.0) | 36 (44.4) | 36 (44.4) | 181 (44.7) |
| >3 | 2 (2.5) | 7 (8.8) | 1 (1.2) | 5 (6.2) | 2 (2.5) | 17 (4.2) |
| Concomitant ASMs taken by ≥15% of all patients, n (%) | ||||||
| Lacosamide | 33 (40.7) | 32 (40.0) | 39 (47.6) | 32 (39.5) | 36 (44.4) | 172 (42.5) |
| Levetiracetam | 27 (33.3) | 28 (35.0) | 34 (41.5) | 30 (37.0) | 35 (43.2) | 154 (38.0) |
| Lamotrigine | 26 (32.1) | 24 (30.0) | 26 (31.7) | 29 (35.8) | 33 (40.7) | 138 (34.1) |
| Valproate c | 19 (23.5) | 26 (32.5) | 20 (24.4) | 23 (28.4) | 12 (14.8) | 100 (24.7) |
| Oxcarbazepine | 12 (14.8) | 19 (23.8) | 20 (24.4) | 14 (17.3) | 10 (12.3) | 75 (18.5) |
| Perampanel | 16 (19.8) | 15 (18.8) | 15 (18.3) | 12 (14.8) | 11 (13.6) | 69 (17.0) |
| Brivaracetam | 12 (14.8) | 14 (17.5) | 10 (12.2) | 19 (23.5) | 10 (12.3) | 65 (16.0) |
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.
c
Includes ergenyl chrono, valproate magnesium, valproate semisodium, valproate sodium, and valproic acid.