Cabergoline as a Preventive Treatment for Chronic Migraine
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About
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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Astrid Hjelholt, MD, PhD
Data sourced from clinicaltrials.gov
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