Table 1.
Demographics and baseline disease characteristics of patients in the proof-of-concept trial
| Placebo (n = 27) | Padsevonil (n = 28) | All patients (n = 55) | |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 35.2 (8.7) | 36.2 (11.4) | 35.7 (10.1) |
| Median (range) | 37.0 (21–51) | 35.5 (18–60) | 36 (18–60) |
| Age category (years), n (%) | |||
| ≤18 | 0 | 2 (7.1) | 2 (3.6) |
| 19–<65 | 27 (100) | 26 (92.9) | 53 (96.4) |
| ≥65 | 0 | 0 | 0 |
| Sex, n (%) | |||
| Male | Female | 13 (48.1) | 14 (51.9) | 13 (46.4) | 15 (53.6) | 26 (47.3) | 29 (52.7) |
| Body mass index (kg/m2) | |||
| Mean (SD) | 25.66 (4.82) | 27.20 (4.32) | 26.45 (4.59) |
| Median (range) | 25.30 (16.9–34.9) | 27.55 (18.5–34.7) | 26.60 (16.9–34.9) |
| Race, n (%) | |||
| Black | 0 | 1 (3.6) | 1 (1.8) |
| White | 27 (100) | 25 (89.3) | 52 (94.5) |
| Other/mixed | 0 | 2 (7.1) | 2 (3.6) |
| Age at epilepsy onset (years)a | |||
| Mean (SD) | 13.10 (9.55) | 9.21 (7.70) | 11.08 (8.77) |
| Median (range) | 13.02 (0–45.0) | 8.93 (0–34.8) | 9.71 (0–45) |
| Epilepsy duration (years) | |||
| Mean (SD) | 22.75 (11.27) | 27.19 (11.81) | 25.01 (11.66) |
| Median (range) | 22.09 (1.5–40.6) | 26.02 (12.0–49.7) | 24.24 (1.5–49.7) |
| History of status epilepticus, n (%) | 3 (11.1) | 3 (10.7) | 6 (10.9) |
| Seizure type, n (%)b | |||
| Focal | 27 (100) | 28 (100) | 55 (100) |
| Focal aware | 10 (37.0) | 8 (28.6) | 18 (32.7) |
| Focal impaired awareness | 22 (81.5) | 27 (96.4) | 49 (89.1) |
| Focal to bilateral | 9 (33.3) | 8 (28.6) | 17 (30.9) |
| Generalized | 0 | 1 (3.6) | 1 (1.8) |
| Unclassified | 1 (3.7) | 1 (3.6) | 2 (3.6) |
| Baseline weekly seizure frequency | |||
| Focal seizures, median (range) | 12.60 (3.0–130.6) | 8.00 (3.2–35.7)c | 8.24 (3.0–130.6) |
| All seizures, median (range) | 15.40 (3.0–130.6) | 8.08 (3.2–214.7) | 10.23 (3.0–214.7) |
| Number of prior AEDsd, n (%) | |||
| <4 | 0 | 0 | 0 |
| 4–5 | 3 (11.1) | 5 (17.9) | 8 (14.5) |
| 6–7 | 3 (11.1) | 3 (10.7) | 6 (10.9) |
| 8–10 | 9 (33.3) | 12 (42.9) | 21 (38.2) |
| >10 | 12 (44.4) | 8 (28.6) | 20 (36.4) |
| Number of concomitant AEDs, n (%) | |||
| 1 | 2 (7.4) | 3 (10.7) | 5 (9.1) |
| 2 | 8 (29.6) | 9 (32.1) | 17 (30.9) |
| 3 | 9 (33.3) | 9 (32.1) | 18 (32.7) |
| 4 | 6 (22.2) | 3 (10.7) | 9 (16.4) |
| ≥5 | 2 (7.4) | 4 (14.2) | 6 (10.9) |
| Active vagus nerve stimulation, n (%) | 10 (37.0) | 5 (17.9) | 15 (27.3) |
AED = antiepileptic drug; SD = standard deviation.
a
Data are from 25 patients in the placebo group and 27 in the padsevonil group (52 patients overall).
b
Patients could have reported more than one seizure type.
c
Data are from 27 patients (54 patients overall).
d
AEDs started before the date of first dose of trial drug.