TABLE 1.
Patient baseline demographics and characteristics (mITT/safety population) a
| Open‐label | Double‐blind | |||
|---|---|---|---|---|
| 1.0 mg Staccato alprazolam (n = 8) | Staccato alprazolam | |||
| Staccato placebo (n = 40) | 1.0 mg (n = 38) | 2.0 mg (n = 38) | ||
| Demographics | ||||
| Mean age (range), years | 48.1 (24–69) | 33.1 (21–58) | 34.8 (18–62) | 33.5 (18–66) |
| Female, n (%) | 8 (100.0) | 20 (50.0) | 21 (55.3) | 26 (68.4) |
| Mean duration of epilepsy (range), years | 32.4 (6.9–63.1) | 23.1 (1.4–52.7) | 20.1 (1.0–52.3) | 23.1 (2.9–50.4) |
| Type of seizure with a predictable pattern b , n (%) | ||||
| Clusters (multiple seizures) | 3 (37.5) | 22 (55.0) | 27 (71.1) | 28 (73.7) |
| Prolonged focal seizures | 4 (50.0) | 18 (45.0) | 10 (26.3) | 9 (23.7) |
| Flurries of generalized seizures | 1 (12.5) | 4 (10.0) | 4 (10.5) | 4 (10.5) |
| Concomitant ASMs taken by ≥20% of patients in any group, n (%) | ||||
| Lamotrigine | 2 (25.0) | 17 (42.5) | 15 (39.5) | 14 (36.8) |
| Levetiracetam | 3 (37.5) | 16 (40.0) | 13 (34.2) | 15 (39.5) |
| Clonazepam | 2 (25.0) | 12 (30.0) | 10 (26.3) | 13 (34.2) |
| Lacosamide | 2 (25.0) | 9 (22.5) | 13 (34.2) | 13 (34.2) |
| Lorazepam | 4 (50.0) | 8 (20.0) | 12 (31.6) | 8 (21.1) |
| Topiramate | 0 | 5 (12.5) | 9 (23.7) | 8 (21.1) |
| Cannabidiol | 0 | 9 (22.5) | 5 (13.2) | 6 (15.8) |
| Zonisamide | 4 (50.0) | 4 (10.0) | 3 (7.9) | 4 (10.5) |
Abbreviations: ASM, antiseizure medication; mITT, modified intent‐to‐treat population.
a
All 124 patients in the safety population were included in the mITT.
b
Patients could have had more than one type of seizure with a predictable pattern and were not stratified by seizure type.