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OpenTrials
Completed

NCT Number: NCT05525611

Cabergoline as a Preventive Treatment for Chronic Migraine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus N, Central Jutland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabergoline 0.5 MG

Drug

Cabergoline 0.5 mg once a week in 12 weeks

Placebo

Other

Placebo once a week in 12 weeks

Primary outcomes

  1. A change in days with headache in patients with chronic migraine

    Time frame: 12 weeks

    Based on a headache diary

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2022
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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