Cabergoline as a preventive migraine treatment: A randomized clinical pilot trial
Abstract
Background 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. Methods 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). Results 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’…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 101 participants or records.
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