๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the efficacy, safety, and tolerability of cabergoline for the prevention of episodic migraine in adults with 4-14 monthly migraine days (MMD). The main questions it aims to answer are:
1. Does once-weekly cabergoline (0.5 mg or 1.0 mg) reduce MMD compared to placebo?
2. What are the effects of cabergoline on headache severity, acute medication use, and patient-reported outcomes?
3. Is cabergoline safe to use in individuals with migraine?
Participants will:
Complete a 4-week baseline period to document migraine frequency and classify headache days.
Be randomly assigned to one of three treatment arms:
1. Cabergoline 0.5 mg/week
2. Cabergoline 1.0 mg/week
3. Placebo
Participate in a 12-week double-blind treatment phase, followed by a 12-week open-label treatment phase where all participants rec
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 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 โฅ 15 MMD during the baseline period
* Chronic migraine (โฅ15 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 (โฅ3 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
๐
What it tests
- Cabergoline 0.5 MG
- Placebo
- Cabergoline 1 MG
Aarhus University Hospital
Aarhus N, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.