OnabotulinumtoxinA (n=688) | Placebo (n=696) | p Value | |
---|---|---|---|
Mean age, years | 41.1 | 41.5 | 0.579 |
Female, % | 87.6 | 85.2 | 0.185 |
Caucasian, % | 89.7 | 90.5 | 0.602 |
Mean headache days | 19.9 | 19.8 | 0.498 |
Mean moderate/severe headache days | 18.1 | 18.0 | 0.705 |
Mean total cumulative hours of headache occurring on headache days | 295.93 | 281.22 | 0.021 |
Mean total HIT-6 score* | 65.5 | 65.4 | 0.638 |
Patients with severe (≥60) HIT-6 score, %* | 93.5 | 92.7 | 0.565 |
Patients overusing acute headache medications, %† | 64.8 | 66.1 | 0.450 |
*HIT-6 scores of 36–49 indicate little or no impact; 50–55, some impact; 56–59, substantial impact; 60–78, severe impact.
†Patients must have taken acute headache medication at least twice per week in any week with ≥5 diary days and on ≥10–15 days (depending on the medication category) during the baseline period.
HIT, Headache Impact Test.