G43.9
Conditions
Interventions
Group 1: Placebo (Lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose), 2 tablets/day p.o., for 12 weeks, in addition to treatment as usual
Group 2: Treatment as usua
Sponsors
Universitätsklinikum EssenKlinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age =18 years, history of episodic or chronic migraine (patient self-report and diagnosed by a specialist in neurology according to the International Classification of Headache Disorders (Olesen 2018)) =12 months prior to screening, migraine frequency =4 days per month on average across 3 months prior to screening, consent and fluent German language skills.
Exclusion criteria
Exclusion criteria: Any substance or alcohol abuse, major depression, schizophrenia, suicidality, hypersensitivity or allergy to any ingredient of the placebo pills, participation in another study using investigational drugs within the last 3 months prior to inclusion, and any acute or chronic pain condition apart from migraine. Patients volunteering to attend the optional MRI session must not suffer from claustrophobia or have any implants or devices unsuitable for MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of headache days in 4 weeks from baseline to visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in migraine days in 4 weeks from baseline to visit 3, in mean pain intensity (NRS), days of use of acute medication in 4 weeks, disability (Pain Disability Index, Headache Impact Test), global impression of change (PGIC), quality of life (Short Form Health Survey), count of patients with 50% reduction in primary outcomes (responder rate), safety and tolerability (General Assessment of Side Effects). Explorative outcomes comprise potential predictors. | — |
Countries
Germany
Contacts
Public ContactJulian Kleine-Borgmann
Universitätsklinikum Essen
Outcome results
None listed