Cabergoline for Episodic Migraine
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Aarhus University Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ \< 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
Source: ClinicalTrials.gov · NCT07072910 · last updated 2025-11-18