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

NCT07751497 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-07

No results posted yet for this study

Summary

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.

Conditions

  • Vestibular Migraine

Interventions

DRUG

Rimegepant

Rimegepant ODT 75 mg once daily

DRUG

Flunarizine

Flunarizine 10 mg once nightly

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-12-31
Completion
2029-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751497 on ClinicalTrials.gov