Vestibular migraine is a common condition that causes repeated episodes of dizziness or vertigo, often with migraine headaches, sensitivity to light and sound, and nausea. It affects 1% to 2.7% of the general population and is one of the most frequent diagnoses in dizziness clinics. Despite its prevalence, there is very little high-quality evidence to guide preventive treatment.
This study compares two preventive treatments for vestibular migraine: rimegepant (a newer medication that blocks a protein called CGRP involved in migraine attacks) and flunarizine (a medication commonly used for vestibular migraine prevention in some countries). The study hypothesis is that rimegepant is not inferior to flunarizine in reducing the number of days with moderate-to-severe vestibular symptoms.
Approximately 400 adults aged 18 to 75 with definite vestibular migraine will be enrolled across multiple countries (China, Italy, Spain, and the United Kingdom). Participants will be randomly assigned in a 1:1 ratio to receive either rimegepant 75 mg once daily or flunarizine 10 mg once nightly for 12 weeks. The total study participation is 20 weeks, including a 4-week observation period, a 12-week treatment period, and a 4-week safety follow-up period. Participants will complete daily electronic diaries to record their symptoms throughout the study.
The primary outcome is the change in the number of moderate-to-severe vestibular symptom days from the observation period to weeks 13-16, comparing the two treatment groups. Secondary outcomes include treatment completion rates, changes in monthly migraine days, adverse events, and patient-reported outcomes including dizziness-related disability, anxiety, depression, and global impression of change.
Male or female subjects aged 18 to 75 years；
Diagnosis of definite vestibular migraine per Bárány society criteria： A. At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours； B. Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)；
one sided location
pulsating quality
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 use of any prophylactic medication targeting the calcitonin gene-related peptide (CGRP);
Parallel
Rimegepant
DrugRimegepant ODT 75 mg once daily
Flunarizine
DrugFlunarizine 10 mg once nightly
MVSDs
Change from the observation phase in moderate-to-severe monthly vestibular symptom days (MVSDs) (as defined by Bárány Society) at weeks 13-16. MVSD = monthly vestibular symptom day, prorated to 28 days. Recommend not to specify that groups A and B are being compared in the description of the endpoint per se. (recommendation agreed)
Percentage of participants
Percentage of participants who complete treatment during weeks 5-16.
MVSDs 2
Change from the observation phase in moderate-to-severe MVSDs (as defined by Bárány Society) at weeks 5-8 and weeks 9-12.
TEAEs
Percentage of participants with TEAEs (treatment-emergent adverse events) during weeks 5-16.
MVSDs3
Change from the observation phase in MVSDs (as defined by Bárány Society) at weeks 13-16.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
