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Cabergoline for Episodic Migraine

Study acronym: PROTECT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: University of Aarhus to Aarhus University Hospital Trial status: Not Yet Recruiting to Recruiting · Study sites: 0 to 1 · Start date changed from estimate of Sep 1, 2025 to Nov 12, 2025v3 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2025 to Nov 12, 2025
  2. Eligibility criteria expanded, about 9 words Secondary endpoints revised (33)v2 Show 1 more changeShow less
    • Secondary endpoints revised (33)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07072910
Lead Sponsor Aarhus University Hospital
Conditions Migraine
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov