End Point | Pain Intensity at Treatment Initiation | Double-blind Period | Open-label Period | |
---|---|---|---|---|
nVNS | Sham | nVNS | ||
First Attack | ||||
 % ≥1-point pain improvement | – | 46.8** | 26.2 | 42.9 |
 % without rescue medication | – | 59.3* | 41.9 | 49.1 |
 % pain-free response | Mild | 50.0* | 25.0 | 56.9 |
Moderate | 20.4 | 22.2 | 14.8 | |
Severe | 19.2 | 16.7 | 23.3 | |
All Attacks | ||||
 % ≥1-point pain improvement | – | 39.4** | 26.4 | 41.8 |
 % without rescue medication | – | 52.3** | 37.3 | 49.7 |
 % pain-free response | Mild | 46.7* | 30.1 | 48.6 |
Moderate | 17.1 | 16.1 | 13.8 | |
Severe | 12.2 | 10.3 | 14.6 |