Weekly pill could cut migraine days in half
NCT ID NCT07072910
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a weekly dose of cabergoline, a drug that affects dopamine, can reduce the number of migraine days in adults with episodic migraine (4-14 migraine days per month). 150 participants will be randomly assigned to receive cabergoline (0.5 mg or 1.0 mg) or a placebo once a week for 12 weeks, followed by an open-label phase where everyone gets cabergoline. The study tracks migraine frequency, severity, and medication use through daily diaries and questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cabergoline (Dostinex), a dopamine receptor agonist taken as a weekly oral tablet
- What this could lead to
- If it works, this could provide a new, once-weekly preventive option for people with episodic migraine, reducing the number of migraine days per month.
- What could go wrong
- This is an early phase 2 trial with only 150 participants, so results may not apply to everyone. Cabergoline can cause side effects like nausea, dizziness, or heart valve issues, and it may not prove more effective than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aarhus University Hospital
RECRUITINGAarhus N, 8200, Denmark
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