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โ† Trials
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Cabergoline for Episodic Migraine

RecruitingPhase 2Ages 18 Years - anyAllAarhus University Hospital
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In plain words

What the trial is, and whether it could suit you

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 rec

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 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 โ‰ฅ 15 MMD during the baseline period * Chronic migraine (โ‰ฅ15 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 (โ‰ฅ3 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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What it tests

  • Cabergoline 0.5 MG
  • Placebo
  • Cabergoline 1 MG
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Where

1 site
Aarhus University Hospital
Aarhus N, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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