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

<h4>Background</h4>Beneficial 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.<h4>Methods</h4>In a double-blind, placebo-...

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Main Authors: Astrid Johannesson Hjelholt, Flemming Winther Bach, Helge Kasch, Henrik Støvring, Troels Staehelin Jensen, Jens Otto Lunde Jørgensen
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0320937
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author Astrid Johannesson Hjelholt
Flemming Winther Bach
Helge Kasch
Henrik Støvring
Troels Staehelin Jensen
Jens Otto Lunde Jørgensen
author_facet Astrid Johannesson Hjelholt
Flemming Winther Bach
Helge Kasch
Henrik Støvring
Troels Staehelin Jensen
Jens Otto Lunde Jørgensen
author_sort Astrid Johannesson Hjelholt
collection DOAJ
description <h4>Background</h4>Beneficial 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.<h4>Methods</h4>In 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).<h4>Results</h4>Of 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.<h4>Conclusion</h4>Cabergoline significantly reduced monthly migraine days in episodic migraine without serious adverse effects, supporting further investigation into the use of cabergoline for migraine prevention.
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spelling doaj-art-b604c4ac73014f40aa7f7c9087cc68e82025-08-20T03:27:07ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01204e032093710.1371/journal.pone.0320937Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.Astrid Johannesson HjelholtFlemming Winther BachHelge KaschHenrik StøvringTroels Staehelin JensenJens Otto Lunde Jørgensen<h4>Background</h4>Beneficial 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.<h4>Methods</h4>In 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).<h4>Results</h4>Of 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.<h4>Conclusion</h4>Cabergoline significantly reduced monthly migraine days in episodic migraine without serious adverse effects, supporting further investigation into the use of cabergoline for migraine prevention.https://doi.org/10.1371/journal.pone.0320937
spellingShingle Astrid Johannesson Hjelholt
Flemming Winther Bach
Helge Kasch
Henrik Støvring
Troels Staehelin Jensen
Jens Otto Lunde Jørgensen
Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
PLoS ONE
title Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
title_full Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
title_fullStr Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
title_full_unstemmed Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
title_short Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial.
title_sort cabergoline as a preventive migraine treatment a randomized clinical pilot trial
url https://doi.org/10.1371/journal.pone.0320937
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