Cabergoline for Episodic Migraine

Sponsor
Aarhus University Hospital
Study ID
NCT07072910
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabergoline 0.5 MG — DRUG
    Participants 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 — DRUG
    Participants 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 — DRUG
    Participants 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.

Study Details

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.

Key Dates

First listed
Jul 18, 2025
Start date
Nov 12, 2025
Status verified
Nov 2025
Primary completion
Mar 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabergoline 0.5 mg/Week (Double-Blind Phase)
    Participants in this arm will receive cabergoline 0.5 mg once weekly as add-on treatment for 12 weeks during the double-blind treatment phase.
  • Experimental: Cabergoline 1.0 mg/Week (Double-Blind Phase)
    Participants in this arm will receive cabergoline 1.0 mg once weekly as add-on treatment for 12 weeks during the double-blind treatment phase.
  • Placebo Comparator: Placebo (Double-Blind Phase)
    Participants in this arm will receive a placebo once weekly as add-on treatment for 12 weeks during the double-blind treatment phase.

Primary Outcome Measure

Change in Monthly Migraine Days (MMD) [ Time Frame: Baseline to the last four weeks of the double-blind treatment phase ]

Central Contacts

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