Table 3.
DFN-15 Efficacy versus Placebo
| Placebo | DFN-15 | P value | |
|---|---|---|---|
| Pain freedom, n1/n2a (%) | |||
| 15 minutes | 3/220 (1.4) | 2/223 (0.9) | 0.684 |
| 30 minutes | 15/236 (6.4) | 16/234 (6.8) | 0.855 |
| 45 minutes | 28/240 (11.7) | 30/237 (12.7) | 0.780 |
| 1 hour | 38/240 (15.8) | 55/237 (23.2) | 0.049 |
| 1.5 hours | 61/242 (25.2) | 86/238 (36.1) | 0.010 |
| 2 hours | 76/244 (31.1) | 110/238 (46.2) | <0.001 |
| 4 hours | 122/244 (50.0) | 148/239 (61.9) | 0.010 |
| 24 hours | 184/245 (75.1) | 199/240 (82.9) | 0.045 |
| Pain relief, n1/n2a (%) | |||
| 15 minutes | 24/220 (10.9) | 26/223 (11.7) | 0.881 |
| 30 minutes | 65/236 (27.5) | 74/234 (31.6) | 0.363 |
| 45 minutes | 89/240 (37.1) | 113/237 (47.7) | 0.021 |
| 1 hour | 105/240 (43.8) | 133/237 (56.1) | 0.008 |
| 1.5 hours | 129/242 (53.3) | 158/238 (66.4) | 0.004 |
| 2 hours | 148/244 (60.7) | 177/238 (74.4) | 0.001 |
| 4 hours | 183/244 (75.0) | 198/239 (82.8) | 0.044 |
| 24 hours | 218/245 (89.0) | 225/240 (93.8) | 0.075 |
| Nausea freedom, n1/n2a (%) | |||
| 15 minutes | 16/110 (14.5) | 14/102 (13.7) | 1.000 |
| 30 minutes | 32/119 (26.9) | 33/105 (31.4) | 0.465 |
| 45 minutes | 51/122 (41.8) | 47/106 (44.3) | 0.789 |
| 1 hour | 64/122 (52.5) | 55/106 (51.9) | 1.000 |
| 1.5 hours | 74/123 (60.2) | 72/107 (67.3) | 0.275 |
| 2 hours | 83/124 (66.9) | 74/107 (69.2) | 0.778 |
| 4 hours | 92/124 (74.2) | 91/107 (85.0) | 0.051 |
| 24 hours | 108/124 (87.1) | 101/108 (93.5) | 0.125 |
| Photophobia freedom, n1/n2a (%) | |||
| 15 minutes | 14/187 (7.5) | 15/187 (8.0) | 1.000 |
| 30 minutes | 29/202 (14.4) | 43/196 (21.9) | 0.052 |
| 45 minutes | 45/204 (22.1) | 72/199 (36.2) | 0.002 |
| 1 hour | 57/204 (27.9) | 87/199 (43.7) | 0.001 |
| 1.5 hours | 73/206 (35.4) | 105/200 (52.5) | <0.001 |
| 2 hours | 95/207 (45.9) | 128/200 (64.0) | <0.001 |
| 4 hours | 130/207 (62.8) | 157/201 (78.1) | <0.001 |
| 24 hours | 176/208 (84.6) | 185/202 (91.6) | 0.033 |
| Phonophobia freedom, n1/n2a (%) | |||
| 15 minutes | 12/141 (8.5) | 16/156 (10.3) | 0.693 |
| 30 minutes | 24/154 (15.6) | 45/64 (27.4) | 0.014 |
| 45 minutes | 40/155 (25.8) | 64/166 (38.6) | 0.017 |
| 1 hour | 53/55 (34.2) | 73/166 (44.0) | 0.086 |
| 1.5 hours | 67/155 (43.2) | 94/167 (56.3) | 0.026 |
| 2 hours | 76/156 (48.7) | 113/167 (67.7) | <0.001 |
| 4 hours | 92/156 (59.0) | 128/168 (76.2) | 0.001 |
| 24 hours | 128/157 (81.5) | 153/169 (90.5) | 0.024 |
| Change in functional disability, 2 hours, mean (SD), 0–3 scale | |||
| 2 hours | −0.6 (0.83) | −0.9 (0.87) | <0.001 |
| 4 hours | −1.0 (0.95) | −1.2 (0.94) | 0.006 |
| 24 hours | −1.5 (0.88) | −1.5 (0.88) | 0.693 |
| Use of rescue medication, 2–24 hours, n1/n2b | 45/245 (18.4) | 40/240 (16.7) | 0.635 |
| Treatment satisfaction, 1–7 scalec | |||
| 2 hours | 3.6 | 3.1 | 0.003 |
| 4 hours | 3.5 | 2.9 | 0.006 |
| Treatment satisfaction, 24 hours, 0–100 scaled | 3.5 | 3.9 | 0.004 |
| Sustained (2–24 hours) pain freedom,e n1/n2f (%) | 52/191 (27.2) | 76/189 (40.2) | 0.009 |
| Sustained (2–24 hours) pain relief,e n1/n2f (%) | 98/191 (51.3) | 119/189 (63.0) | 0.023 |
Notes: an1 = number of responders; n2 = number of assessments. bExcludes patients who took rescue prior to recording the 2-hour time point and subjects with pre-dose pain level of none (Grade 0); n1 = number of subjects with use of rescue medication within 2 to 24 hours and n2 = number of subjects with non-missing assessments for use of rescue medication criteria. cLower scores indicate greater satisfaction; assessments were done at 2 and 24 hours post-dose. dPPMQ-R Total Score based on a composite transformed scale (0–100) where a higher score means greater satisfaction. eEndpoints were prespecified but reanalyzed post hoc due to an error in statistical methodology. fn1 = number of patients with pain freedom at 2 hours post-dose, with no use of rescue medication between 2 hours and 24 hours post-dose, and no recurrence of headache pain within 2 to 24 hours post-dose; n2 = number of patients with non-missing pain assessment at 2, 4, and 24 hours post-dose