Cabergoline as a Preventive Treatment for Chronic Migraine

NCT05525611 | Completed

• 1 other identifier: Migraine_2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• A change in days with headache in patients with chronic migraine

  Based on a headache diary

  12 weeks

Study Arms (2)

Cabergoline

EXPERIMENTAL

Drug: Cabergoline 0.5 MG

Control

PLACEBO COMPARATOR

Other: Placebo

Interventions

Cabergoline 0.5 MG DRUG

Cabergoline 0.5 mg once a week in 12 weeks

Cabergoline

Placebo OTHER

Placebo once a week in 12 weeks

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine and more than 6 days with headache every months

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus N, Central Jutland, 8200, Denmark

Location

Related Publications (1)

• Hjelholt AJ, Bach FW, Kasch H, Stovring H, Jensen TS, Jorgensen JOL. Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial. PLoS One. 2025 Apr 1;20(4):e0320937. doi: 10.1371/journal.pone.0320937. eCollection 2025.

  PMID: 40168298 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled parallel study with a 12 weeks duration.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: September 1, 2022
• Study Start: September 5, 2022
• Primary Completion: June 13, 2023
• Study Completion: August 8, 2023
• Last Updated: February 26, 2024

Record last verified: 2022-03

Locations

DK (1)