Table 1.
Demographic and Baseline Characteristics of Patients Entering the Extension Phase of Study 232.
| Cohort 1: ≥7 to <12 years (n = 22) |
Cohort 2: ≥2 to <7 years (n = 19) |
Total (N = 41) |
|
|---|---|---|---|
| Age, years, mean (SD) | 9.1 (1.36) | 4.5 (1.17) | 7.0 (2.65) |
| Gender, n (%) | |||
| Male | 15 (68.2) | 13 (68.4) | 28 (68.3) |
| Female | 7 (31.8) | 6 (31.6) | 13 (31.7) |
| Weight, kg, mean (SD) | 38.08 (15.43) | 20.07 (6.28) | 29.73 (15.01) |
| Height, cm, mean (SD) | 136.20 (13.03) | 107.49 (16.63) | 123.36 (20.51) |
| BMI, kg/m2, mean(SD) | 19.31 (4.86) | 19.63 (12.02) | 19.45 (8.68) |
| Time since diagnosis, years, mean (SD) | 5.77 (2.89) | 3.80 (1.50) | 4.86 (2.53) |
| Seizure type (past 2 years), n (%) | |||
| Focal seizuresa | 19 (86.4) | 15 (78.9) | 34 (82.9) |
| Generalized seizuresb | 6 (27.3) | 12 (63.2) | 18 (43.9) |
| Unclassified seizures | 1 (4.5) | 1 (5.3) | 2 (4.9) |
| Number of AEDs, n (%) | |||
| 1 AED | 4 (18.2) | 6 (31.6) | 10 (24.4) |
| 2 AEDs | 13 (59.1) | 11 (57.9) | 24 (58.5) |
| 3 AEDs | 5 (22.7) | 2 (10.5) | 7 (17.1) |
Abbreviations: AED, antiepileptic drug; BMI, body mass index; SD, standard deviation.
a Focal seizures include simple focal seizures without motor signs, simple focal seizures with motor signs, complex focal seizures, and focal seizures with secondarily generalized seizures.
b Generalized seizures include absence, myoclonic, clonic, tonic, tonic-clonic, and atonic (astatic).