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Cabergoline as a Preventive Treatment for Chronic Migraine

NCT05525611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-26

No results posted yet for this 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.

Conditions

Interventions

DRUG

Cabergoline 0.5 MG

Cabergoline 0.5 mg once a week in 12 weeks

OTHER

Placebo

Placebo once a week in 12 weeks

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2023-06-13
Completion
2023-08-08

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525611 on ClinicalTrials.gov