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Cabergoline for Episodic Migraine (PROTECT)
EU CTIS ID: 2025-522323-10-00
What this study is testing
To compare the efficacy of once-weekly cabergoline 0.5 mg and 1.0 mg versus placebo in reducing migraine frequency in patients with episodic migraine.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Episodic migraine with or without aura as defined by ICHD, 3rd edition, present for at least 12 months
- 4–14 MMD in the last 3 months prior to inclusion
- Male or female subjects ≥18 years of age
- Written informed consent
You likely can't join if
- < 4 MMD or ≥ 15 MMD during the baseline period
- 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 are breast-feeding
- Known hypersensitivity or allergy to compounds similar to the investigational medicinal product
- Inability, in the opinion of the investigator, to understand or comply with study medication or procedures, or any condition which, in the investigator’s judgement, may render the subject unable to complete the study
- Presumed medication-overuse headache (MOH)
See the full eligibility criteria
- Episodic migraine with or without aura as defined by ICHD, 3rd edition, present for at least 12 months
- 4–14 MMD in the last 3 months prior to inclusion
- Male or female subjects ≥18 years of age
- Written informed consent
- < 4 MMD or ≥ 15 MMD during the baseline period
- 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 are breast-feeding
- Known hypersensitivity or allergy to compounds similar to the investigational medicinal product
- Inability, in the opinion of the investigator, to understand or comply with study medication or procedures, or any condition which, in the investigator’s judgement, may render the subject unable to complete the study
- Presumed medication-overuse headache (MOH)
- Trigeminal autonomic cephalalgias and neuralgias
- Secondary headache conditions
- Women who have a positive pregnancy test at randomization
- 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)
- Changes in concomitant migraine-specific treatment within the 3 months prior to inclusion, or any planned adjustments to such treatment during the study period
- History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease
- Severe untreated hypertension
- Psychiatric disorders requiring pharmacological treatment
- Chronic migraine (≥15 headache days per month)
- Concurrent participation in another clinical trial that, in the judgement of the investigator, may interfere with the conduct or outcomes of the present study
- Use of drugs with dopamine antagonistic or agonistic properties
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.