Table 1.
Demographics and baseline characteristics (safety population).
| Characteristic | SoC plus nVNS (n = 48) | Control (n = 49) |
|---|---|---|
| Age, y, mean (SD) | 45.4 (11.0) | 42.3 (11.0) |
| Sex, n (%) | ||
| Male | 34 (71) | 33 (67) |
| Time since onset of chronic CH disorder, y, mean (SD)a | 4.7 (3.9) | 5.0 (3.7) |
| CH attack duration, min, mean (SD) | ||
| With acute pharmacologic medications/oxygenb | 27.4 (19.8) | 29.3 (29.9) |
| Without acute pharmacologic medications/oxygenc | 95.2 (57.7) | 103.3 (66.8) |
| Number of CH attacks in the four weeks before enrolment, mean (SD)c | 67.3 (43.6) | 73.9 (115.8) |
| Use of prophylactic medications for CH, n (%) | ||
| Verapamil/verapamil hydrochloride | 25 (52) | 26 (53) |
| Lithium/lithium carbonate | 6 (13) | 9 (18) |
| Topiramate | 7 (15) | 7 (14) |
| Corticosteroids | 2 (4) | 2 (4) |
| Use of pharmacologic medications/oxygen for the acute treatment of CH, n (%) | ||
| Pharmacologic medications | 43 (90) | 44 (90) |
| Oxygen | 32 (67) | 34 (69) |
CH: cluster headache; nVNS: non-invasive vagus nerve stimulation; SD: standard deviation; SoC: standard of care; y: years.
a
Data were missing for two participants in the control group.
b
Data were missing for one participant in the control group.
c
Data were missing for one participant in the SoC plus nVNS group.