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. 2020 Apr 30;34(6):661–672. doi: 10.1007/s40263-020-00726-4

Table 1.

Overall demographics and baseline characteristics (safety population)

Placebo (n = 6) CBD (n = 28) Total (N = 34)
Age (years) 26.9 ± 7.0 30.1 ± 11.1 29.5 ± 10.5
Sex
 Male 5 (83) 17 (61) 22 (65)
 Female 1 (17) 11 (39) 12 (35)
Race, white 6 (100) 28 (100) 34 (100)
Height (cm) 178.3 ± 6.9 174.3 ± 13.5 175.0 ± 12.6
Weight (kg) 86.0 ± 18.3 81.9 ± 22.2 82.7 ± 21.4
Body mass index (kg/m2) 27.0 ± 5.3 26.8 ± 5.4 26.8 ± 5.3
STP arm Placebo (n = 2) CBD (n = 12) Total (n = 14)
 Daily STP dose (mg/day) 1250 (500–2000) 625 (500–2000) 625 (500–2000)
 No. receiving any AEDa 2 (100) 11 (92) 13 (93)
 Most common AEDs (≥ 10%) in any treatment group
  Lacosamide 2 (100) 3 (25) 5 (36)
  Clobazam 0 (0) 4 (33) 4 (29)
  VPA 0 (0) 3 (25) 3 (21)
  Ethosuximide 0 (0) 2 (17) 2 (14)
  Lamotrigine 0 (0) 2 (17) 2 (14)
  Topiramate 0 (0) 2 (17) 2 (14)
  VPA sodium 0 (0) 2 (17) 2 (14)
  Levetiracetam 1 (50) 0 (0) 1 (7)
  Rufinamide 1 (50) 0 (0) 1 (7)
VPA arm Placebo (n = 4) CBD (n = 16) Total (n = 20)
 Daily VPA dose (mg/day) 1450 (900–2500) 1015 (200–1950) 1115 (200–2500)
 No. receiving any AEDa 4 (100) 16 (100) 20 (100)
 Most common AEDs (≥ 10%) in any treatment group
  Lacosamide 0 (0) 3 (19) 3 (15)
  Clobazam 0 (0) 6 (38) 6 (30)
  Lamotrigine 2 (50) 4 (25) 6 (30)
  Carbamazepine 1 (25) 1 (6) 2 (10)
  Levetiracetam 0 (0) 2 (13) 2 (10)
  Lorazepam 1 (25) 1 (6) 2 (10)
  Oxcarbazepine 1 (25) 1 (6) 2 (10)
  Rufinamide 1 (25) 2 (13) 3 (15)
  Clonazepam 1 (25) 2 (13) 3 (15)
  Zonisamide 0 (0) 2 (13) 2 (10)

Data are presented as mean ± standard deviation, n (%), or median (range) unless otherwise indicated

AED antiepileptic drug, CBD cannabidiol, STP stiripentol, VPA valproate

aOther than VPA or STP as required for each arm