A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority Study

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07751497
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Vestibular Migraine

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    Rimegepant ODT 75 mg once daily
  • Flunarizine — DRUG
    Flunarizine 10 mg once nightly

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Dec 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A
    Rimegepant ODT 75 mg once daily
  • Other: Group B
    Flunarizine 10 mg once nightly

Primary Outcome Measure

MVSDs [ Time Frame: from baseline to weeks 13-16 ]

Central Contacts

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