Once-weekly cabergoline to prevent episodic migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial enrolls adults with episodic migraine who report 4–14 monthly migraine days. After a 4-week baseline to document migraine frequency, participants are randomized to once-weekly cabergoline 0.5 mg, cabergoline 1.0 mg, or placebo for 12 weeks. All participants then enter a 12-week open-label phase where everyone receives cabergoline to assess longer-term effects, adherence, and tolerability, followed by a safety follow-up. Primary and secondary outcomes include change in monthly migraine days, headache severity, acute medication use, patient-reported outcomes, and safety measures.

Why it matters

Who can join: the full rules

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 and neuralgias
* Secondary headache conditions
* Other common primary headache types (e.g. tension-type headache) if attacks are frequent (present on an average of \>1 day/month and \>12 days/year)
* Presumed medication-overuse headache
* Recent changes in preventive migraine treatment (≥3 months prior to study inclusion)
* History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease
* Severe untreated hypertension
* Use of drugs with dopamine antagonistic or agonistic properties
* Psychiatric disorders requiring pharmacological treatment
* Women of child-bearing potential (i.e. not chemically or surgically sterilized, or not postmeno-pausal) and male participants with partners of child-bearing potential, who are unwilling to use a medically accepted method of contraception, considered reliable by the investigator, from signing of informed consent and throughout the study
* Women who have a positive pregnancy test at randomization
* Women who are breast-feeding
* 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

Where it's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting

Study contacts

• Study coordinator: Astrid Hjelholt, M.D., Ph.D.
• Email: ajh@clin.au.dk
• Phone: 004524800664

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.