Table 1.
Outcomes | Data source | Timepoint |
---|---|---|
Primary Outcome Migraine days per 28 days |
M-sense electronic diary |
Baseline vs. month 6 |
Secondary outcomes | ||
Responder rate (patients with ≥50% reduction from baseline in migraine days/month) |
M-sense electronic diary |
First six months in the study |
Headache days per 28 days |
M-sense electronic diary |
Baseline vs. month 6 |
Days of acute medication intake |
M-sense electronic diary |
Baseline vs. month 6 |
HIT-6 score | Study databank | Baseline vs. month 6 |
EQ-5D-5L score | Study databank | Baseline vs. month 6 |
PROMIS 29 scores | Study databank | Baseline vs. month 6 |
Overall health care costs | Claims' data | Six months prior study initiation versus six months after study initiation |
Days with inability to work | Claims' data | Six months prior study initiation versus six months after study initiation |
HIT-6, Headache Impact-Test 6; PROMIS 29, Patient-Reported Outcome-measurement Information System.