Cabergoline as a Preventive Migraine Treatment: An Investigator-Initiated Randomized Controlled Trial

Abstract

BackgroundBeneficial effects of dopamine agonist treatment on migraine have been reported but remain to be properly tested.Aimto examine the effect of cabergoline as preventive treatment for migraine.Primary endpointChange in monthly migraine days (MMD).MethodsIn a randomized, double-blind, placebo-controlled pilot study, 36 adults with episodic and chronic migraine were enrolled. Following a 28-days baseline period, participants received cabergoline 0.5 mg or placebo once weekly for 12 weeks as add-on treatment. An electronic headache diary was completed by the participant, and pertinent headache questionnaires and blood tests were collected at baseline and following the treatment period. The trial was registered withClinicalTrials.gov(NCT05525611).FindingsMean (SD) baseline MMD was 13.6 (4.1) in the cabergoline group and 14.0 (5.3) in the placebo group. In participants with episodic migraine (n= 20), the change in mean MMD (SE) from baseline to the last 28 days of the treatment period was -5.4 (1.3) (cabergoline) as compared to -1.8 (0.9) (placebo) [odds ratio: 0.79 (95% CI 0.65 - 0.95), p=0.014]. In participants with chronic migraine (n=13), the reduction in MMD with cabergoline was not significant (p=0.6). Patients’ global impression of change significantly improved after cabergoline as compared to placebo in the entire group of participants (p=0.006). The number of participants with episodic migraine achieving ≥ 50% reduction in MMD tended to increase after cabergoline (p=0.07). Seven participants receiving cabergoline and 4 participants receiving placebo experienced adverse effects, none of which were serious.InterpretationsPreventive cabergoline treatment exhibited clinically meaningful improvement in episodic migraine without serious adverse effects. This provides proof-of-concept to justify a sufficiently powered phase 2 trial with different cabergoline dosing regimens as preventive treatment of episodic migraine.FundingThis study has received no external funding.