Table 1.
Demographic and baseline characteristics (safety population).
| By treatment
group (n = 102) |
By
cohort (n = 102) |
|||
|---|---|---|---|---|
| Characteristic | nVNS (n = 50) | Sham (n = 52) | eCH (n = 30) | cCH (n = 72) |
| Age, mean (SD), y | 43.9 (10.6) | 46.9 (10.6) | 42.9 (12.7) | 46.5 (9.6) |
| Male, No. (%) | 35 (70.0) | 38 (73.1) | 22 (73.3) | 51 (70.8) |
| Ethnic origin, No. (%) | ||||
| White | 49 (98.0) | 52 (100.0) | 30 (100.0) | 71 (98.6) |
| Black | 0 | 0 | 0 | 0 |
| Asian | 1 (2.0) | 0 | 0 | 1 (1.4) |
| Duration of CH attacks during run-in period, mean (SD), min | 69.9 (68.7) | 77.4 (76.9) | 69.6 (83.3) | 76.1 (69.0) |
| CH type, No. (%) | ||||
| eCH | 15 (30.0) | 15 (28.8) | 30 (100.0) | 0 |
| cCH | 35 (70.0) | 37 (71.2) | 0 | 72 (100.0) |
| Number of attacks per week (median, min/max) | 10, 1–53 | 11, 2–39 | 10, 1–53 | 11, 2–39 |
| Medications used to manage CH, No. (%) | ||||
| Triptans | 37 (74.0) | 34 (65.3) | 19 (63.3) | 52 (72.2) |
| Oxygen | 27 (54.0) | 31 (59.6) | 20 (66.7) | 38 (52.8) |
| Mild analgesics | 7 (14.0) | 6 (11.5) | 2 (6.7) | 11 (15.3) |
| Narcotics | 3 (6.0) | 0 | 1 (3.3) | 2 (2.8) |
| Verapamil | 18 (36.0) | 23 (44.2) | 11 (36.7) | 30 (41.7) |
| Lithium | 4 (8.0) | 4 (7.7) | 1 (3.3) | 7 (9.7) |
| Propranolol | 1 (2.0) | 0 | 0 | 1 (1.4) |
| Tricyclic antidepressants | 2 (4.0) | 1 (1.9) | 1 (3.3) | 2 (2.8) |
| Serotonin receptor antagonists | 2 (4.0) | 2 (3.8) | 1 (3.3) | 3 (4.2) |
| Antiepileptics | 10 (20.0) | 6 (11.5) | 3 (10.0) | 13 (18.1) |
| Corticosteroids | 1 (2.0) | 2 (3.8) | 1 (3.3) | 2 (2.8) |
| Other | 5 (10.0) | 8 (15.4) | 4 (13.3) | 9 (12.5) |
| None | 0 | 5 (9.6) | 1 (3.3) | 4 (5.6) |
| One or more preventives | 32 (64.0) | 33 (63.4) | 15 (50.0) | 50 (69.5) |
Abbreviations: cCH: chronic cluster headache; CH: cluster headache; eCH: episodic cluster headache; nVNS; non-invasive vagus nerve stimulation; SD: standard deviation.