Tests cabergoline to prevent episodic migraine in adults

Trial details

Who runs it

Aarhus University Hospital

Trial code

NCT07072910EU 2025-522323-10-00

Record updated

18 November 2025

Original description

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:Read full original descriptionShow less

Prevention and Treatment of Episodic Migraine by Cabergoline Therapy (PROTECT). A Randomized, Placebo-controlled, Double-blind, Investigator-initiated Trial

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 receive cabergoline (0.5 mg or 1.0 mg once weekly).

Record daily headache activity, acute medication use, and severity using an electronic diary.

Complete validated headache questionnaires and provide blood samples for biomarker analysis at baseline, week 12, and week 24.

The study also includes exploratory analyses of genetic predictors of treatment response and metabolic markers to assess the broader effects of cabergoline.

Inclusion: 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: Presumed medication-overuse headache; Recent changes in preventive migraine treatment (≥3 months prior to study inclusion); Use of drugs with dopamine antagonistic or agonistic properties; Concurrent participation in another clinical trial that, in the judgement of the investigator, may interfere with the conduct or outcomes of the present study; Secondary headache conditions; History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease; Severe untreated hypertension; Psychiatric disorders requiring pharmacological treatment; Allergy or hypersensitivity to cabergoline or similar compounds; 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; < 4 MMD or ≥ 15 MMD during the baseline period; Chronic migraine (≥15 headache days per month); Trigeminal autonomic cephalalgias and neuralgias; 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); 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.

ClinicalTrials.gov NCT07072910 · EU CTIS 2025-522323-10-00