Table 2 Summary of Pre-Treatment Disease Characteristics and Outcome Measures
Persistent PTH (n = 89) | |
|---|---|
Disease Characteristics during 28-day Pre-Treatment Phase | |
Headache days of any severity, mean (SD) | 24.6 ± 6.1 |
Headache days of moderate to severe intensity, mean (SD) | 15.7 ± 9.6 |
Days with use of any acute headache medication, mean (SD) | 4.0 ± 4.4 |
HIT-6 score, mean (SD) | 61.6 ± 5.2 |
Primary Outcome Measure | |
Mean change in number of monthly headache days of moderate to severe intensity from baseline to week 9–12 (SD) | −2.8 (6.8) |
Secondary Outcome Measures | |
Mean change in number of monthly headache days of any intensity from baseline to week 9–12 (SD) | −1.7 (6.9) |
≥ 25% reduction in mean monthly headache days of any intensity, baseline to week 12, % | 21 |
≥ 50% reduction in mean monthly headache days of any intensity, baseline to week 12, % | 13 |
≥ 75% reduction in mean monthly headache days of any intensity, baseline to week 12, % | 6 |
Mean change in HIT-6 score from baseline to week 12 (SD) | −4.6 (7.3) |
Post-Hoc Explorative Outcome Measures | |
≥ 25% reduction in mean monthly headache days of moderate to severe intensity, baseline to week 12, % | 47 |
≥ 50% reduction in mean monthly headache days of moderate to severe intensity, baseline to week 12, % | 28 |
≥ 75% reduction in mean monthly headache days of moderate to severe intensity, baseline to week 12, % | 13 |
Mean change in number of monthly days using acute headache medications, baseline to week 9–12 (SD) | −0.4 (5.2) |