Table 1.
Demographics and baseline disease characteristics
| Safety population | Randomized safety population | ||
|---|---|---|---|
| MDZ–NS (N = 292) | MDZ–NS (n = 134) | Placebo (n = 67) | |
| Age (years) | |||
| Mean (SD) | 33.0 (11.96) | 34.0 (11.23) | 31.5 (12.83) |
| Median (range) | 31.5 (12–65) | 32.0 (14–61) | 27.0 (12–62) |
| Age group, n (%) | |||
| <18 years | 18 (6.2) | 5 (3.7) | 5 (7.5) |
| ≥18 to <65 years | 272 (93.2) | 129 (96.3) | 62 (92.5) |
| ≥65 years | 2 (0.7) | 0 | 0 |
| Sex, n (%) | |||
| Male | female | 146 (50.0) | 146 (50.0) | 68 (50.7) | 66 (49.3) | 33 (44.8) | 37 (55.2) |
| Race, n (%) | |||
| White | 275 (94.2) | 125 (93.3) | 65 (97.0) |
| Black or African American | 7 (2.4) | 3 (2.2) | 1 (1.5) |
| Other | 5 (1.7) | 2 (1.5) | 1 (1.5) |
| Asian | 2 (0.7) | 2 (1.5) | 0 |
| American Indian or Alaska Native | 2 (0.7) | 2 (1.5) | 0 |
| Native Hawaiian or Other Pacific Islander | 1 (0.3) | 0 | 0 |
| Body mass index (kg/m2) | n = 1 (0.3) | n = 0 | n = 0 |
| Mean (SD) | 26.05 (5.924) | 25.89 (5.745) | 25.01 (5.066) |
| Typical duration of cluster (min) | n = 278 | n = 129 | n = 63 |
| Mean (SD) | 259.10 (548.79) | 270.77 (572.75) | 239.34 (528.05) |
| Median (range) | 67.5 (2.5–4320.0) | 65.0 (2.5–4320.0) | 60.0 (8.5–2880.0) |
| Number of years since clusters onset | n = 283 | n = 133 | n = 63 |
| Mean (SD) | 9.24 (9.93) | 9.88 (10.11) | 6.69 (6.30) |
| Median (range) | 6.0 (0.3–62.0) | 5.0 (0.3–48.0) | 5.0 (0.5–32.0) |
| Number of episodes in year before visit 1 | |||
| Mean (SD) | 50.8 (109.99) | 56.3 (128.53) | 49.1 (98.43) |
| Median (range) | 15 (3–999) | 18 (3–999) | 15 (4–600) |
| Number of seizures in cluster episode | n = 291 | ||
| Mean (SD) | 12.23 (21.02) | 12.81 (23.60) | 14.16 (25.57) |
| Median (range) | 6.0 (2–200) | 5.2 (2–200) | 6.0 (2–170) |
| Seizure type(s) in cluster, n (%)a | |||
| Focal impaired awareness (complex partial) | 153 (52.4) | 71 (53.0) | 33 (49.3) |
| Focal to bilateral (secondary generalized) | 97 (33.2) | 46 (34.3) | 20 (29.9) |
| Focal aware (simple partial) | 60 (20.5) | 23 (17.2) | 17 (25.4) |
| Primary generalized tonic‐clonic | 20 (6.8) | 8 (6.0) | 7 (10.4) |
| Tonic | 18 (6.2) | 8 (6.0) | 3 (4.5) |
| Absence | 13 (4.5) | 7 (5.2) | 0 |
| Other | 11 (3.8) | 7 (5.2) | 0 |
| Myoclonic | 10 (3.4) | 3 (2.2) | 3 (4.5) |
| Atonic | 2 (0.7) | 2 (1.5) | 0 |
All values are based on the safety or randomized safety populations unless specified otherwise. Abbreviations: MDZ–NS, midazolam nasal spray; SD, standard deviation
Patients may have reported >1 seizure type.