Evidence map›Paper›PMID 40168298›Full record

Trial reportPloS one2025

Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.

Astrid Johannesson Hjelholt, Flemming Winther Bach, Helge Kasch, Henrik Støvring, Troels Staehelin Jensen, Jens Otto Lunde Jørgensen

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05525611 nacompletednot on this map

Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial

TypeinterventionalSponsorUniversity of AarhusRan2022 to 2023Enrolled36ConditionsMigraineArmsCabergoline 0.5 MG, Placebo
NCT07072910 phase2recruitingnot on this map

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

TypeinterventionalSponsorAarhus University HospitalRan2025 to 2028Enrolled150ConditionsMigraineArmsCabergoline 0.5 MG, Placebo, Cabergoline 1 MG
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Astrid Johannesson HjelholtSteno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.ORCID 0000-0002-3114-4176
Flemming Winther BachDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Helge KaschDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Henrik StøvringSteno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.
Troels Staehelin JensenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.ORCID 0000-0002-3487-6380
Jens Otto Lunde JørgensenDepartment of Clinical Medicine, Aarhus University, Aarhus, Denmark.ORCID 0000-0001-7408-1526

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBeneficial effects of dopamine agonist treatment on migraine have been reported but remain to be properly tested. The aim of this study was to examine the effect of cabergoline as preventive treatment for migraine.

methodsIn a double-blind, placebo-controlled pilot study, 36 adults with ≥  6 monthly migraine days were enrolled at Aarhus University Hospital. Following a 28-days baseline period, participants were randomized to receive cabergoline 0.5 mg or placebo once weekly for 12 weeks as add-on treatment. An electronic headache diary was completed daily, and headache questionnaires and blood tests were collected at baseline and following the treatment period. Primary outcome was change in monthly migraine days. The trial was registered with ClinicalTrials.gov (NCT05525611).

resultsOf 101 assessed participants, 36 were enrolled. Baseline monthly migraine days were 13.6 (4.1) in the cabergoline group and 14.0 (5.3) in the placebo group. No significant overall difference in the reduction of monthly migraine days was observed. However, among participants with episodic migraine (n = 20), the mean (SE) reduction in monthly migraine days from baseline to the last 28 days of the treatment period was -5.4 (1.3) with cabergoline compared to -1.8 (0.9) with placebo (p = 0.04) [odds ratio: 0.79 (95% CI 0.65 - 0.95), p = 0.014]. In participants with chronic migraine (n = 13), the reduction in monthly migraine days was not significantly different in the two groups. Patients' global impression of change significantly improved after cabergoline treatment as compared to placebo in the entire group of participants (p = 0.006). The number of participants with episodic migraine achieving ≥  50% reduction in monthly migraine days tended to increase after cabergoline (p = 0.07). Adverse effects were reported by seven participants on cabergoline and four on placebo, none of which were serious.

conclusionCabergoline significantly reduced monthly migraine days in episodic migraine without serious adverse effects, supporting further investigation into the use of cabergoline for migraine prevention.

Indexed as

Dopamine AgonistsErgolinesMigraine DisordersAdultCabergolineDouble-Blind MethodFemaleHumansMaleMiddle AgedPilot ProjectsTreatment OutcomeCabergolineDopamine AgonistsErgolines

Identifiers

PMID40168298
PMCPMC11960899

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.