G43
Conditions
Interventions
Group 1: Standardized migraine diagnostics by the pediatrician and adolescent physician and multimodal, interdisciplinary early therapy: Pediatricians and adolescent physicians are provided with speci
Sponsors
Institut für soziale Padiatrie und Jugendmedizin, Ludwig-Maximilians-Universität München
Eligibility
Sex/Gender
All
Age
6 Years to 11 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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
| Measure | Time frame |
|---|---|
| Number of responders (patients with decrease in headache days per 12 weeks from baseline to follow-up by at least 50%); survey via moma app using a headache calendar (basis headache calendar DMKG; http://www.dmkg.de/patienten/dmkg-kopfschmerzkalender.html). Days missed from school per 12 weeks; daily survey via momo app following question5 of the Ped-MIDAS. Days missed from leisure activities per 12 weeks; daily survey via moma app based on question 1 of the Ped-MIDAS Migraine-related limitations in daily life; survey via PedMIDAS Quality of life; survey via moma app using the KINDL® questionnaire. Cumulative headache duration (sum of hours with headache over 12 weeks); survey via momo app using headache calendar Headache severity (averaged over days with headache over 12 weeks). Survey via moma app using Numeric Rating Scale (NRS) of 0-10 (0 = no pain, 10 = most severe pain imaginable). Days taking an acute headache medication per 12 weeks; survey via momo app using a headache calendar. 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. | — |
Countries
Germany
Contacts
Public ContactFlorian Heinen
Integriertes Sozialpädiatrisches Zentrum im Dr. von Haunerschen Kinderspital, iSPZ Campus Hauner, LMU Zentrum für Entwicklung und komplex chronisch kranke Kinder
Outcome results
None listed