Once-weekly cabergoline to prevent episodic migraine
Prevention and Treatment of Episodic Migraine by Cabergoline Therapy (PROTECT). A Randomized, Placebo-controlled, Double-blind, Investigator-initiated Trial
This trial sees if once-weekly cabergoline (0.5 mg or 1.0 mg) can reduce monthly migraine days in adults who have 4–14 migraine days per month.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT07072910 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with episodic migraine per ICHD-3 who have 4–14 monthly migraine days and stable use of acute migraine medications are the intended participants.
Not a fit: People with chronic migraine (≥15 headache days/month), certain cardiac or pulmonary disorders (including history of valve disease), current use of interacting dopamine drugs, or other excluded headache conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective and safe, cabergoline could provide an inexpensive, once-weekly preventive option that reduces monthly migraine days and need for acute medications.
How similar studies have performed: A small pilot study reported that low-dose cabergoline (0.5 mg/week) reduced monthly migraine days and was well tolerated, but larger randomized data are needed to confirm those results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Astrid Hjelholt, M.D., Ph.D.
- Email: ajh@clin.au.dk
- Phone: 004524800664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.