A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment
Overview
- Phase
- Phase 2
- Intervention
- Rimegepant
- Conditions
- Vestibular Migraine
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 240
- Primary Endpoint
- Primary endpoint
- Status
- Not Yet Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •≥1 prior preventive treatment failure
- •E-diary compliance ≥ 80% during observational phase
Exclusion Criteria
- •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;
- •History of ear surgery (except for ear tube surgery);
- •Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo BPPV). Including Meniere's disease, superior semicircular canal prolapse syndrome, vestibular neuritis, persistent postural perceptual vertigo, unilateral or bilateral loss of vestibular function, cerebellar or brainstem disease, multiple sclerosis or sea sickness;
- •Failure of more than 2 preventive migraine drugs;
- •Previous or current treatment with CGRP drugs;
- •History of serious medical or mental illness (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, Raynaud's disease, uncontrollable mental illness, or past psychiatric hospitalization, at the discretion of the treating physician);
- •A history of mania, psychosis, or suicidal ideation;
Arms & Interventions
Group A1:Rimegepant ODT 75mg, QD
Intervention: Rimegepant
Group A2: Placebo, QD
Intervention: Placebo
Outcomes
Primary Outcomes
Primary endpoint
Time Frame: from baseline to weeks 12-16
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 Outcomes
- Secondary objectives for Preventive Treatment Group(from baseline to week 16)