Cabergoline as a Preventive Treatment for Chronic Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Other: Placebo; Drug: Cabergoline 0.5 MG

• Registration Number: NCT05525611
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Study Start: 2022-09-05
• Primary Completion: 2023-06-13
• Study Completion: 2023-08-08
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Cabergoline	Cabergoline 0.5 MG	-

Primary Outcome Measures

Name	Time	Method
A change in days with headache in patients with chronic migraine	12 weeks	Based on a headache diary

Trial Locations

Locations (1)

Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital; 🇩🇰 Aarhus N, Region Midtjylland, Denmark