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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
Rimegepant ODT 75 mg once daily
Flunarizine 10 mg once nightly
Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road
Hangzhou, Zhejiang, China
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)
Time frame: from baseline to weeks 13-16
Percentage of participants
Percentage of participants who complete treatment during weeks 5-16.
Time frame: from baseline to 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.
Time frame: from baseline to weeks 5-8 and weeks 9-12
TEAEs
Percentage of participants with TEAEs (treatment-emergent adverse events) during weeks 5-16.
Time frame: from baseline to weeks 5-16
MVSDs3
Change from the observation phase in MVSDs (as defined by Bárány Society) at weeks 13-16.
Time frame: from baseline to weeks 13-16
MMDs
Change from the observation phase in monthly migraine days (MMDs) at weeks 5-8, weeks 9-12, and weeks 13-16.
Time frame: from baseline to weeks 5-8, weeks 9-12, and weeks 13-16
≥50% reduction
Percentage of participants with ≥50% reduction from the observation phase in moderate-to-severe MVSDs (as defined by Bárány Society) at weeks 13-16.
Time frame: from baseline to weeks 13-16
DHI
Change in dizziness handicap inventory (DHI) score from baseline at week 16.
Time frame: from baseline at week 16
GAD-7
Change in General Anxiety Disorder-7 (GAD-7) score from baseline at week 16.
Time frame: from baseline at week 16
PHQ-9
Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline at week 16.
Time frame: from baseline at week 16
PGIC
Change in Patient Global Impression of Change(PGIC) scale from baseline at week 16.
Time frame: from baseline at week 16
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