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Vestibular MigrainePhase 2VERIFYNCT07751497

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

A Phase 2 study testing Rimegepant and Flunarizine in people with Vestibular Migraine, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Vestibular Migraine
What is being tested?
Rimegepant and Flunarizine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
1 Dec 2026to 1 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 or more migraine features with at least 50% of the vestibular episodes:
  • headache with at least two of the following characteristics:
  • one sided location
  • pulsating quality
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  • moderate or severe pain intensity
  • aggravation by routine physical activity
  • photophobia and phonophobia；
  • visual aura; D. Not better accounted for by another vestibular or ICHD diagnosis.
  • Baseline (day 0 to 28) moderate or severe vestibular symptom days ≥ 4;
  • 80% adherence or better to electronic diary(eDiary) during observational phase
  • VM-PATHI2(Vestibular Migraine Patient Assessment Tool and Handicap Inventory) score > 25 at screening and baseline visit;
  • Written informed consent must be obtained before patient enrolled;
  • Fluency in local main language;
  • Access to email, and cell phone.

Who cannot join

  • 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);
  • Prior or current treatment with flunarizine;
  • Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets;
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  • 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;
  • Other conditions judged by the investigator as unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kaiming Liu contact

+8615068862055

2314411@zju.edu.cn

China1 site

  • Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road

    Hangzhou, Zhejiang, 310000

    Kaiming Liu, 86+15068862055, 2314411@zju.edu.cn

Other trials in China

About this study

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.

Read more

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.

Being tested
Rimegepant, Flunarizine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    Rimegepant ODT 75 mg once daily

  • FlunarizineDrug

    Flunarizine 10 mg once nightly

Study groups in NCT07751497
Study groupRoleWhat they receive
Group AExperimentalRimegepant ODT 75 mg once daily
Receives: Drug: Rimegepant
Group BOtherFlunarizine 10 mg once nightly
Receives: Drug: Flunarizine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: from baseline to weeks 13-16

Secondary outcomes (10)

  1. Percentage of participants

    Percentage of participants who complete treatment during weeks 5-16.

    Measured: from baseline to weeks 5-16

  2. 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.

    Measured: from baseline to weeks 5-8 and weeks 9-12

  3. TEAEs

    Percentage of participants with TEAEs (treatment-emergent adverse events) during weeks 5-16.

    Measured: from baseline to weeks 5-16

  4. MVSDs3

    Change from the observation phase in MVSDs (as defined by Bárány Society) at weeks 13-16.

    Measured: from baseline to weeks 13-16

  5. MMDs

    Change from the observation phase in monthly migraine days (MMDs) at weeks 5-8, weeks 9-12, and weeks 13-16.

    Measured: from baseline to weeks 5-8, weeks 9-12, and weeks 13-16

  6. ≥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.

    Measured: from baseline to weeks 13-16

  7. DHI

    Change in dizziness handicap inventory (DHI) score from baseline at week 16.

    Measured: from baseline at week 16

  8. GAD-7

    Change in General Anxiety Disorder-7 (GAD-7) score from baseline at week 16.

    Measured: from baseline at week 16

  9. PHQ-9

    Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline at week 16.

    Measured: from baseline at week 16

  10. PGIC

    Change in Patient Global Impression of Change（PGIC) scale from baseline at week 16.

    Measured: from baseline at week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07751497
Sponsor's protocol ID
2026-0703
Acronym
VERIFY
Status last verified
Jun 2026
First submitted
3 Aug 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Shao J, Fu J, Zhou M, Ren Z, Li L, Gao L, Xia Y, Zhao Z, Yang M, He J, Xue S, Wang G, He J, Liu K. Effectiveness of rimegepant in vestibular migraine: a prospective self-controlled cohort study. J Headache Pain. 2025 Dec 22;26(1):289. doi: 10.1186/s10194-025-02243-5.

    PubMed 41430107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rimegepant and Flunarizine in people with Vestibular Migraine, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kaiming Liu (+8615068862055, 2314411@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MVSDs (time frame: from baseline to weeks 13-16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07751497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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