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