Cabergoline as a Preventive Treatment for Chronic Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525611
• Other study ID #: Migraine_2022
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: March 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 8, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Cabergoline 0.5 MG
Cabergoline 0.5 mg once a week in 12 weeks

Other:
• Placebo
Placebo once a week in 12 weeks

Locations

Country	Name	City	State
Denmark	Medical Research Laboratory, Department of Clinical Medicine, Endocrinology and Internal Medicine, Aarhus University Hospital	Aarhus N	Region Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in days with headache in patients with chronic migraine	Based on a headache diary	12 weeks