Actively Recruiting
Cabergoline for Episodic Migraine
Led by Aarhus University Hospital · Updated on 2025-11-18
150
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cabergoline for Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with episodic migraine according to ICHD-3 criteria
- Experiencing 4 to 14 monthly migraine days in the past 3 months
- Stable use of acute migraine medication for at least 3 months prior to joining
- Provided written informed consent
You will not qualify if you...
- Fewer than 4 or 15 or more monthly migraine days during the baseline period
- Chronic migraine with 15 or more headache days per month
- Trigeminal autonomic cephalalgias or neuralgias
- Secondary headache conditions
- Frequent tension-type headaches occurring more than 1 day per month and over 12 days per year
- Presumed medication-overuse headache
- Changes in preventive migraine treatment within 3 months before the study
- History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease
- Severe untreated hypertension
- Use of drugs affecting dopamine receptors
- Psychiatric disorders requiring medication
- Women of child-bearing potential and male partners unwilling to use reliable contraception
- Positive pregnancy test at randomization
- Breastfeeding women
- Allergy or sensitivity to cabergoline or similar drugs
- Concurrent participation in interfering clinical trials
- Inability to understand or comply with study procedures or medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
A
Astrid Hjelholt, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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