Modules on migraine activity

Not Applicable

Recruiting

Conditions: G43
Migraine

Registration Number: DRKS00016698

Lead Sponsor: Institut für soziale Padiatrie und Jugendmedizin, Ludwig-Maximilians-Universität München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 786

Inclusion Criteria

Age at inclusion 6-11 years
- Diagnosis of migraine (ICD-10 G43.x) by a pediatrician or adolescent physician using the child-adapted ICHD-3beta criteria for migraine without aura (ICHD-3beta diagnosis 1.1), migraine with aura (ICHD-3beta diagnosis 1.2), or chronic migraine (ICHD-3beta diagnosis 1.3)
- History of migraine for at least 3 months
- History of at least 3 headache days in the last 3 months
- Beta-blocker, amitryptiline, topiramate (migraine prophylaxis medication) allowed if unchanged throughout study duration

Exclusion Criteria

- Reduced intelligence (IQ<70)
- Severe physical or mental, acute or chronic illness other than headache
- Hemiplegic migraine (genetically confirmed)
- Fewer than 3 headache days during the 12-week (84-days) baseline period

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Headache days per 12 weeks; survey via moma app using a headache calendar (basis headache calendar DMKG; http://www.dmkg.de/patienten/dmkg-kopfschmerzkalender.html).<br>The change from baseline (week -12 to 0) to follow-up (week 13-24) is used for all outcome parameters, or for the PedMIDAS and KINDL questionnaires the change from the survey at the end of the baseline period to the survey at the end of the follow-up period. To track progression, the change from baseline to the treatment period (weeks 1-12) will also be evaluated as an exploratory analysis.

Secondary Outcome Measures