TABLE 1.
Patient demographics and baseline characteristics
| Characteristic | Study 1, N = 119 | Study 2, N = 87 | |||
|---|---|---|---|---|---|
| FFA .7 mg/kg/day | FFA .2 mg/kg/day | Placebo | FFA .4 mg/kg/day | Placebo | |
| n | 40 | 39 | 40 | 43 | 44 |
| Age, years | |||||
| Mean ± SD (median) | 8.8 ± 4.4 (8.5) | 9.0 ± 4.5 (8.0) | 9.2 ± 5.1 (8.5) | 8.8 ± 4.6 (9.0) | 9.4 ± 5.1 (9.0) |
| Minimum, maximum | 2, 18 | 2, 17 | 2, 18 | 2, 18 | 2, 19 |
| Age < 6 years, n (%) | 11 (28) | 9 (23) | 11 (28) | 12 (28) | 12 (27) |
| Males, n (%) | 21 (52) | 22 (56) | 21 (52) | 23 (53) | 27 (61) |
| Race, n (%) | |||||
| Caucasian | 34 (85) | 33 (85) | 31 (78) | 23 (53) | 29 (66) |
| Asian | 1 (3) | 2 (5) | 4 (10) | 2 (5) | 1 (2) |
| Other or not reported a | 5 (12) | 4 (10) | 5 (12) | 18 (42) | 14 (31) |
| Concomitant ASMs, n (%) | |||||
| Stiripentol | 0 | 0 | 0 | 43 (100) | 44 (100) |
| Valproate, all forms | 25 (62) | 24 (62) | 22 (55) | 38 (88) | 39 (89) |
| Clobazam | 24 (60) | 24 (62) | 22 (55) | 40 (93) | 42 (96) |
| Topiramate | 11 (28) | 10 (26) | 9 (22) | 14 (33) | 7 (16) |
| Levetiracetam | 4 (10) | 11 (28) | 11 (28) | 6 (14) | 5 (11) |
| Body weight, kg | |||||
| Mean ± SD | 31.8 ± 13.5 | 35.1 ± 19.6 | 31.7 ± 16.2 | 31.3 ± 14.9 | 36.2 ± 21.1 |
| BMI, kg/m2 | |||||
| Mean ± SD | 18.5 ± 3.5 | 19.3 ± 5.7 | 18.0 ± 3.8 | 17.3 ± 2.7 | 19.1 ± 4.9 |
| Median (minimum, maximum) number of seizures during 6‐week baseline period | 26.0 (7, 186) | 25.0 (7, 913) | 40.5 (5, 221) | 22.0 (4, 320) | 16.0 (4, 244) |
| Baseline convulsive seizure‐free days per 28 days | |||||
| Mean ± SD (median) | 15.2 ± 7.6 (17.6) | 16.4 ± 6.7 (18.7) | 13.3 ± 7.7 (13.3) | 18.0 ± 7.4 (20.0) | 19.0 ± 6.4 (21.0) |
| Minimum, maximum | 0, 24.0 | 0, 24.7 | 0, 24.7 | 0, 25 | 0, 26 |
Abbreviations: ASM, antiseizure medication; BMI, body mass index; FFA, fenfluramine.
a
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