Cabergoline for Episodic Migraine

Launched by UNIVERSITY OF AARHUS · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called cabergoline can help prevent episodic migraines—those that happen regularly but not every day—in adults who experience between 4 and 14 migraine days each month. The study wants to see if taking cabergoline once a week can reduce the number of migraine days, lessen headache severity, reduce the need for other migraine medications, and if the medicine is safe to use.

If you join the study, you’ll first track your migraine patterns for four weeks. Then, you’ll be randomly assigned to take either a low dose or a higher dose of cabergoline once a week, or a placebo (a pill with no active medicine), without knowing which one you’re getting. This phase lasts 12 weeks. After that, everyone will take cabergoline for another 12 weeks. You’ll keep a daily diary on your headaches and medication use, complete questionnaires about your symptoms, and give blood samples at the start, middle, and end of the study. To join, you need to be 18 or older, have episodic migraines as described, and have been using the same migraine medications for at least three months. Certain health conditions and medications might make you ineligible. This study is not yet recruiting, but it aims to better understand if cabergoline could be a helpful and safe option for preventing migraines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Episodic migraine according to ICHD-3 criteria
• • 4-14 monthly migraine days (MMD) in the last 3 months prior to inclusion
• • Stable acute migraine medication use for at least 3 months prior to inclusion
• • Written informed consent
• Exclusion Criteria:
• • \< 4 MMD or ≥ 15 MMD during the baseline period
• • Chronic migraine (≥15 headache days per month)
• • Trigeminal autonomic cephalalgias, neuralgias, or secondary headache disorders
• • Medication overuse headache
• • Recent changes in preventive migraine treatment (≥3 months prior to study inclusion)
• • Heart valve disease or severe untreated hypertension
• • Use of dopamine antagonists or agonists
• • Psychiatric disorders requiring treatment
• • Pregnancy, breastfeeding
• • Women of child-bearing potential (i.e. those who are not chemically or surgically sterilized or who are not post-menopausal), and male participants with a partner who is a woman of child-bearing potential, who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator, from the time of signing the in-formed consent, throughout the study, and for at least one month after the end of treatment with the investigational medicinal product (IMP)
• • Allergy or hypersensitivity to cabergoline or similar compounds
• • Concurrent participation in another clinical trial that, in the judgement of the investigator, may interfere with the conduct or outcomes of the present study
• • Inability of the subject, in the opinion of the investigator, to understand and/or comply with study medications or procedures, or any conditions that, in the opinion of the investigator, may render the subject unable to complete the study