Vestibular migraine (VM) is one of the most common vestibular disorders, affecting 1.0% to 2.7% of the general population1, 7% of patients with definite migranous vertigo in dizziness clinics2, as well as 10.3% of VM patients in headache clinics3; 65% to 85% of VM patients are female1. Despite the relative prevalence of vestibular migraine, evidence-based medicine remains scarce. Two Cochrane reviews published in 2023 found that there is almost no evidence to support the use of medications for the acute treatment or preventive treatment of VM4,5.
Calcitonin gene-related peptide (CGRP) has been established as an excellent target for the treatment of migraine. Animal studies suggest a link between CGRP and vestibular disorders. A prospective observational cohort study found that monoclonal antibodies targeting CGRP receptors and ligands were very effective for vestibular migraine (VM), with 90% of participants experiencing at least a 50% reduction in vertigo attacks6. A small-scale prospective randomized controlled trial showed that a monoclonal antibody targeting a CGRP ligand significantly reduced the number of dizziness days per month in VM patients compared to placebo7. The efficacy of CGRP small molecule antagonists for the preventive and acute treatment of migraines has been widely recognized8,9. Therefore, we speculate that Rimegepant is effective for the preventive and acute treatment of vestibular migraine.
By focusing on a large sample RCT, our study can offer new evidence-based treatment options for patients with vestibular migraine. This is crucial, as many patients with vestibular migraine may not respond well to conventional migraine treatments. Our findings could guide clinicians in choosing more effective therapeutic strategies.
Specifically in acute treatment of vestibular migraine, triptans have failed to show superiority when compared to placebo in treatment vestibular migraine symptoms10. Prochlorperazine, a vestibular sedative, is widely used for acute treatment of vestibular migraine but is known to chronify symptoms11. Should rimegepant demonstrate superiority to placebo in this study, rimegepant could potentially become the first-line treatment for vestibular migraine across the world.
Male or female aged 18 to 75 years
Documentation of a VM diagnosis according to the Barany Society/ ICHD-31
More than 4 definite dizzy days per month in the 3 months prior to screen
E-diary compliance ≥ 80% during observational phase
Pregnant women, lactating women, or reluctance to use approved contraception during study participation;
There is a condition or abnormality that the investigator believes will affect the safety of the patients or the quality of the data;
Allergic to the ingredients of Remeipine sulfate or sulfate;
Previous treatment with remejepam;
Parallel
Rimegepant
DrugTake 75mg qd of oral sulfate remigipan orally disintegrating tablets
Placebo
DrugTake 75mg qd of oral Rimegepan oral tablets with placebo
Primary endpoint
Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 for participants measured daily from the observational phase compared to weeks 12-16.
Secondary objectives for Preventive Treatment Group
Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 every 4 weeks during the 12-week treatment period compared to baseline
Secondary objectives for Preventive Treatment Group
Change in the number of vestibular symptom attacks every 4 weeks compared to baseline over the 12-week treatment period. (Since VM attacks may recur multiple times within a day, each lasting a short duration, we need to further clearly define what constitutes "one attack.")
Secondary objectives for Preventive Treatment Group
Change in the number of monthly migraine days (MMD) every 4 weeks compared to baseline over the 12-week treatment period
Secondary objectives for Preventive Treatment Group
Change in Migraine Disability Assessment (MIDAS) score from baseline to week 16
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