Cabergoline as a Preventive Treatment for Chronic Migraine

Last updated: February 23, 2024
Sponsor: University of Aarhus
Overall Status: Completed

Phase

N/A

Condition

Pain (Pediatric)

Headaches

Oral Facial Pain

Treatment

Cabergoline 0.5 MG

Placebo

Clinical Study ID

NCT05525611
Migraine_2022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Migraine and more than 6 days with headache every months

Exclusion

Exclusion Criteria:

  • Cardiac valve disease
  • Hypertension
  • Psychiatric disease
  • Treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides anditraconazole
  • pregnant or breastfeeding

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Cabergoline 0.5 MG
Phase:
Study Start date:
September 05, 2022
Estimated Completion Date:
August 08, 2023

Connect with a study center

  • Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital

    Aarhus N, Region Midtjylland 8200
    Denmark

    Site Not Available

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