Table 1 Demographic and baseline characteristics of patients enrolled in the dose-blinded extension (efficacy analysis set)
Characteristics | Epti 100 mg / Epti 100 mg (n = 286) | Epti 300 mg / Epti 300 mg (n = 282) | Placebo / Epti 100 mg (n = 144) | Placebo / Epti 300 mg (n = 146) |
|---|---|---|---|---|
Age, mean (SD), years | 44.7 (10.6) | 43.0 (10.1) | 44.8 (11.0) | 43.2 (10.7) |
Sex, no. (%) | ||||
Female | 264 (92.3) | 249 (88.3) | 124 (86.1) | 132 (90.4) |
Male | 22 (7.7) | 33 (11.7) | 20 (13.9) | 14 (9.6) |
Race, no. (%) | ||||
White | 276 (96.5) | 270 (95.7) | 138 (95.8) | 139 (95.2) |
Other | 0 | 0 | 1 (0.7) | 1 (0.7) |
Unknown | 10 (3.5) | 12 (4.3) | 5 (3.5) | 6 (4.1) |
MMDs, mean | 13.7 | 13.6 | 13.7 | 14.0 |
Days per month of acute headache medication use, mean | 11.1 | 11.0 | 11.2 | 11.2 |
HIT-6 total score, mean | 66.6 | 66.5 | 66.4 | 66.0 |
MSQ, mean | ||||
Role function restrictive | 35.6 | 35.7 | 35.6 | 35.4 |
Role function preventive | 50.3 | 51.3 | 51.4 | 49.8 |
Emotional function | 50.6 | 48.4 | 48.4 | 49.0 |
EQ-5D-5L VAS, mean | 76.0 | 74.6 | 75.4 | 72.6 |
WPAI, mean | ||||
Absenteeism | 11.8 | 11.7 | 10.7 | 14.4 |
Presenteeism | 50.8 | 53.5 | 49.7 | 53.3 |
Work productivity loss | 53.8 | 57.2 | 52.8 | 57.7 |
Activity impairment | 58.3 | 58.9 | 58.8 | 59.0 |