A Placebo Controlled, National, Multi-center, Randomized Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: the REVIVAL Study
- Conditions
- Vestibular MigraineAdults 18 Years and Older (no Other Exclusion Criteria)
- Interventions
- Drug: Rimegepant ODT 75mg , EOD treatment for 4/12* weeksDrug: Placebo, EOD treatment for 4/12* weeks
- Registration Number
- NCT06748664
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 240
1.Male or female aged 18 to 75 years;2.Documentation of a VM or pVM diagnosis according to the Barany Society;3.More than 4 definite dizzy days per month in the 3 months prior to screen;4.VM-PATHI score > 25 at screening and baseline visit;5.E-diary compliance ≥ 80% during observational phase
1.Pregnant women, lactating women, or reluctance to use approved contraception during study participation; 2. There is a condition or abnormality that the investigator believes will affect the safety of the patients or the quality of the data; 3. Allergic to the ingredients of Remeipine sulfate or sulfate; 4. Previous treatment with remejepam; 5. History of ear surgery (except for ear tube surgery); 6. 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; 7. Failure of more than 2 preventive migraine drugs; 8. Previous or current treatment with CGRP drugs; 9. 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); 10. A history of mania, psychosis, or suicidal ideation; 11. acceptable if no more than two drugs for migraine prevention (prescribed specifically for this purpose) are used and the dose has stabilized for 2 months before the start of the study; 12. History of drug or alcohol abuse based on the subject's medical record or self-reported report within 12 months before the screening period; 13. Bototoxin (e. g., Dysport®, ®, Xeomin®, Myobloc®, and JeuveauTM) for the head, face, or neck during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A1:Rimegepant ODT 75mg, EOD Rimegepant ODT 75mg , EOD treatment for 4/12* weeks Rimegepant ODT 75mg, EOD treatment for 4/12\* weeks Group A2: Placebo, EOD Placebo, EOD treatment for 4/12* weeks Placebo, EOD treatment for 4/12\* weeks
- Primary Outcome Measures
Name Time Method Primary objective for Preventive Treatment Group measured daily from the observational phase compared to weeks 12-16. Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society for participants measured daily from the observational phase compared to weeks 12-16.
- Secondary Outcome Measures
Name Time Method Secondary objectives for Preventive Treatment Group: every 4 weeks during the 12-week treatment period compared to baseline 1. Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society every 4 weeks during the 12-week treatment period compared to baseline
Secondary objectives for Preventive Treatment Group from baseline to 16 Change in Vestibular Activities of Daily Living Scale (VADL) score from baseline to 16.