Migraine
Conditions
Brief summary
Headache disorders constitute a major global disease burden, and migraine - with a one-year prevalence of 15 % - is the sixth most disabling condition. Though a common disease, the pathogenesis is still unclear. Thus, the treatments have different mechanisms of action and preventive treatments are only effective in approximately 50% of chronic migraine patients. Recent evidence from mice models and a study of prolactine-associated headaches have indicated that dopamine agonists such as cabergoline might be used as a treatment of migraine. The aim of this study is to test the hypothesis that the dopamine agonist cabergoline can be used as a treatment of chronic migraine. A randomized controlled trial of 24 patients with chronic migraine will be conducted, comparing cabergoline to placebo as an add-on medication to the patients' migraine treatment over a 12 weeks period. The primary outcome is change in migraine frequency, but also headache-related hospital contacts, and quality of life as well as prolactin levels and biomarkers of the pituitary-gonadal-axis. The results of the study will help understand the pathogenesis of migraine and might also introduce a more effective and affordable preventive migraine treatment.
Interventions
Cabergoline 0.5 mg once a week in 12 weeks
OTHERPlacebo
Placebo once a week in 12 weeks
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, placebo-controlled parallel study with a 12 weeks duration.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Migraine and more than 6 days with headache every months
Exclusion criteria
* Cardiac valve disease * Hypertension * Psychiatric disease * Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole * pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A change in days with headache in patients with chronic migraine | 12 weeks | Based on a headache diary |
Countries
Denmark
Outcome results
None listed