Prevention and Treatment of Episodic Migraine by Cabergoline Therapy (PROTECT). A Randomized, Placebo-controlled, Double-blind, Investigator-initiated Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Written informed consent

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Contact Information
Primary
Astrid Hjelholt, M.D., Ph.D.
ajh@clin.au.dk
004524800664
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov