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. 2021 Oct 22;63(1):130–138. doi: 10.1111/epi.17106

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.

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