The R-E-V-I-V-A-L Study
- Conditions
- Vestibular Migraine
- Interventions
- Drug: Placebo
- Registration Number
- NCT06992674
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
-
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
- Vestibular hypofunction (unilateral or bilateral)
- History of ear surgery (other than ear tubes)
- Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo (BPPV)), including Meniere's disease, superior semicircular canal dehiscence syndrome, vestibular neuritis, persistent postural-perceptual dizziness, unilateral or bilateral vestibular hypofunction, cerebellar or brainstem disorders, multiple sclerosis, or motion sickness.
- Prior or current treatment with a CGRP medication
- Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets.
- Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during the study participation
- History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, and uncontrolled psychiatric disease or past psychiatric hospitalization)
- A history of severe medical or psychiatric conditions (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, renal disease, liver disease, Raynaud's disease, uncontrolled psychiatric disorders, or previous psychiatric hospitalizations) as determined by the treating physician
- A history of mania, psychosis, or suicidal ideation
- A history of drug or alcohol abuse within the 12 months prior to screening, based on the subject's medical records or self-report
- Individuals who have received head, face, or neck botulinum toxin injections (such as Dysport®, Botox®, Xeomin®, Myobloc®, and JeuveauTM) within 4 months before screening or are scheduled for such injections during the study period
- Unwilling to use approved form of birth control during the study
- Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start
- Other conditions judged by the investigator as unsuitable for inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A1:Rimegepant ODT 75mg, EOD Rimegepant - Group A2: Placebo, QD Placebo -
- Primary Outcome Measures
Name Time Method Moderate/Severe vestibular symptom days 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 Outcome Measures
Name Time Method the number of vestibular symptom attacks every 4 weeks compared to baseline over the 12-week treatment period 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.")
MIDAS from baseline to week 16 Change in Migraine Disability Assessment (MIDAS) score from baseline to week 16
percentage reduction in moderate/severe vestibular symptom days from baseline to weeks 12-16 Change in response rate (100%,75%,50%,25%,0%) by percentage reduction in moderate/severe vestibular symptom days from baseline to weeks 12-16
DHI from baseline to week 16 Change in dizziness handicap inventory (DHI) score from baseline to week 16
MMD every 4 weeks compared to baseline over the 12-week treatment period Change in the number of monthly migraine days (MMD) every 4 weeks compared to baseline over the 12-week treatment period
VADL from baseline to week 16 Change in Vestibular Activities of Daily Living Scale (VADL) score from baseline to week 16
PHQ-9 from baseline to week 16 Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 16
GAD-7 from baseline to week 16 Change in General Anxiety Disorder-7 (GAD-7) score from baseline to week 16
PGIC from baseline to week 16 Change in Patient Global Impression of Change（PGIC scale）from baseline to week 16
MSQ from baseline to week 16 Change in Migraine-Specific Quality of Life (MSQ) score from baseline to week 16
Moderate/Severe vestibular symptom days every 4 weeks during the 12-week treatment period compared to baseline 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
Trial Locations
- Locations (1)
Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road
🇨🇳Hangzhou, Zhejiang, China
Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road🇨🇳Hangzhou, Zhejiang, China