Cabergoline for Episodic Migraine
ConditionMigraine
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
< 4 MMD or ≥ 15 MMD during the baseline period
Chronic migraine (≥15 headache days per month)
Trigeminal autonomic cephalalgias and neuralgias
Secondary headache conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Cabergoline 0.5 MG
DrugParticipants will receive cabergoline 0.5 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 0.5 mg during the double-blind phase will continue with the same 0.5 mg dose in the open-label phase.
Placebo
DrugParticipants will receive placebo as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. In the open-label phase, these participants will transition to active cabergoline treatment, receiving either 0.5 mg or 1.0 mg once weekly, depending on their randomized allocation at the start of the open-label phase. The placebo tablets will be formulated to match the cabergoline tablets in size, shape, and color, and should be taken under the same conditions.
Cabergoline 1 MG
DrugParticipants will receive cabergoline 1.0 mg as oral tablets, taken once weekly as an add-on treatment for 12 weeks during the double-blind treatment phase. Participants who received cabergoline 1.0 mg during the double-blind phase will continue with the same 1.0 mg dose in the open-label phase.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Cabergoline 0.5 mg/Week (Double-Blind Phase)Experimental treatment 1 intervention
Group B: Cabergoline 1.0 mg/Week (Double-Blind Phase)Experimental treatment 1 intervention
Group C: Placebo (Double-Blind Phase)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Monthly Migraine Days (MMD)
Change in MMD from baseline to the last four weeks of the double-blind treatment phase. Migraine days are defined according to ICHD-3 criteria or the use of migraine-specific acute medication, recorded in a daily, electronic diary.
Time frame
Baseline to the last four weeks of the double-blind treatment phaseSecondary outcomes
1
Responder rate (proportion of participants achieving ≥50% reduction in MMD)
Proportion of participants achieving ≥50% reduction in MMD during the last four weeks of the 12-week double-blind treatment phase (50% responder rate).
Time frame
Baseline to the last four weeks of the double-blind treatment phase.2
Change in number of moderate/severe headache days
Change in number of moderate/severe headache days from baseline to the last four weeks of the double-blind treatment phase.
Time frame
Baseline to the last four weeks of the double-blind treatment phase.3
Headache severity
Proportion of attacks classified as mild, moderate, or severe at the last four weeks of the double-blind treatment phase.
Time frame
The last four weeks of the double-blind treatment phase.4
Changes in acute medication use.
Change in number of days with use of acute migraine-specific medication from baseline to the last four weeks of the double-blind treatment phase.
Time frame
Baseline to the last four weeks of the double-blind treatment phase.Other outcomes
1
Pharmacogenetic predictors of treatment response.
Genotyping of all participants for variants in the prolactin receptor and dopaminergic pathways previously associated with migraine and drug response.
Time frame
Baseline2
Cost-effectiveness.
Estimation of cost per responder and cost per QALY gained. This analysis will be descriptive and exploratory.
Time frame
Baseline to the end of the double-blind phase (week 12) and the end of the the open-label phase (week 24).3
Change in serum prolactin.
Change in serum prolactin levels from baseline to the end of the double-blind and open-label treatment phases. Descriptive analyses will be performed, and potential associations between prolactin levels and treatment response will be explored.
Time frame
Baseline to the end of the double-blind phase (week 12) and the end of the the open-label phase (week 24).4
Exploratory Subgroup Analyses of Efficacy Outcomes
Stratified analyses of pre-specified efficacy outcomes (e.g., MMD, responder rate, acute medication use, HIT-6, MIDAS, WPAI, PGIC) will be conducted by subgroups including sex, menopausal status, migraine with/without aura, presence of dopaminergic symptoms, and number of prior preventive treatments. These analyses are exploratory and intended to assess consistency of treatment effects across clinically relevant subgroups.
Time frame
Baseline to the end of the double-blind phase (week 12) and the end of the the open-label phase (week 24).Sponsors and contacts
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Source ClinicalTrials.gov