Migraine endpoints come from what participants record at home: headache days, severity, symptoms and medication. Capture runs the daily diary on participants' phones with windows and reminders, and keeps visits, safety and randomisation in the same study.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Headache diary
Thursday · Day 19
Did you have a headache today?
Worst pain today
Symptoms (select all)
Acute medication taken?
What matters in migraine trials
The diary
A preventive migraine trial asks participants to record every day for months, including the many days without a headache. The diary therefore has to be fast on a good day (one question) and thorough on a bad day (duration, severity, symptoms, aura, medication). Skip logic does exactly that: answering "No" to a headache ends the entry.
Migraine day definitions are specific: a headache of sufficient duration with migraine features, or one treated with a migraine-specific acute medication, typically counts as a migraine day. The diary must capture the fields those rules use, as structured answers, so the classification can be applied consistently in analysis.
Acute treatment trials instead ask participants to treat a qualifying attack and record pain and symptoms at defined time points (for example 0, 30 minutes, 1, 2, 24 and 48 hours after dosing). The most bothersome symptom is chosen before treatment. Time-stamped entries in a phone diary are far more reliable than recall at the next visit.
Eligibility usually requires a minimum number of migraine days during the baseline period and a minimum diary completion rate. Running the baseline diary in the same study as treatment keeps the eligibility check and the endpoint on the same data.
Baseline
9.5
Month 3
4.0
Diary days
27/28
58% reduction: responder
Compliance
Completion windows stop participants filling in a week of entries from memory, and a reminder ladder prompts them when an entry is due, the next day and before the window closes, respecting quiet hours. The dashboard shows at-risk participants so sites can intervene before a month is compromised.
At-risk participants
Try it on your own phone in the free sandbox.
Study build
Written into the protocol and reflected in diary fields.
Length, minimum migraine days and minimum diary compliance.
Daily, by type, for medication-overuse and endpoint rules.
Time points after dosing and most bothersome symptom chosen before treatment.
Weekly review of at-risk participants.
C-SSRS for CNS-active drugs where the protocol requires.
Endpoints
| Endpoint | Trial type | Diary fields needed |
|---|---|---|
| Change in monthly migraine days | Preventive | Headache yes/no, duration, severity, migraine features, migraine-specific medication. |
| 50% responder rate | Preventive | Same as above, per participant per month. |
| Monthly headache days | Preventive | Any headache of defined duration. |
| Acute medication days | Preventive | Acute medication taken, by type. |
| Pain freedom at 2 hours | Acute | Pain severity at dosing and at 2 hours after dosing. |
| Most bothersome symptom freedom at 2 hours | Acute | Symptom chosen before dosing, presence at 2 hours. |
| Sustained pain freedom | Acute | Pain from 2 to 24 or 48 hours, rescue medication use. |
Beyond headache days
Headache days tell only part of the story. Preventive trials commonly add periodic questionnaires on migraine-related disability and impact, such as the Migraine Disability Assessment (MIDAS) or the Headache Impact Test (HIT-6), and migraine-specific quality of life measures. These are completed monthly or at visits rather than daily, so they belong on the visit schedule alongside the daily diary. Check the terms of use for each instrument before you build it.
Because the same participants are completing a daily diary, keep periodic questionnaires short and schedule them on days with a visit or a reminder already planned. More on scheduling different questionnaires in one study in ePRO software.
Usually change from baseline in monthly migraine days, with the 50% responder rate as a key secondary endpoint.
FDA guidance uses pain freedom at 2 hours and freedom from the most bothersome symptom at 2 hours as co-primary endpoints.
Completion windows ensure daily entries, skip logic keeps headache-free days quick, and missed days are visible immediately.
No. The diary opens in the phone browser from a secure link.
Yes, in the free sandbox with every feature.
Daily diaries with windows and reminders. Free sandbox.