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Vestibular MigrainePhase 2NCT06748664

A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

A Phase 2 study testing Rimegepant in people with Vestibular Migraine and Adults 18 Years and Older (no Other Exclusion Criteria), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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
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Trial summary

Vestibular migraine (VM) is one of the most common vestibular disorders, affecting 1.0% to 2.7% of the general population1, 7% of patients with definite migranous vertigo in dizziness clinics2, as well as 10.3% of VM patients in headache clinics3; 65% to 85% of VM patients are female1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Rimegepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 1 May 2027
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 aged 18 to 75 years
  • Documentation of a VM diagnosis according to the Barany Society/ ICHD-31
  • More than 4 definite dizzy days per month in the 3 months prior to screen
  • ≥1 prior preventive treatment failure
  • E-diary compliance ≥ 80% during observational phase

Who cannot join

  • Pregnant women, lactating women, or reluctance to use approved contraception during study participation;
  • There is a condition or abnormality that the investigator believes will affect the safety of the patients or the quality of the data;
  • Allergic to the ingredients of Remeipine sulfate or sulfate;
  • Previous treatment with remejepam;
  • History of ear surgery (except for ear tube surgery);
  • Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo BPPV). Including Meniere's disease, superior semicircular canal prolapse syndrome, vestibular neuritis, persistent postural perceptual vertigo, unilateral or bilateral loss of vestibular function, cerebellar or brainstem disease, multiple sclerosis or sea sickness;
Show all 13Show fewer
  • Failure of more than 2 preventive migraine drugs;
  • Previous or current treatment with CGRP drugs;
  • History of serious medical or mental illness (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, Raynaud's disease, uncontrollable mental illness, or past psychiatric hospitalization, at the discretion of the treating physician);
  • A history of mania, psychosis, or suicidal ideation;
  • Acceptable if no more than two drugs for migraine prevention (prescribed specifically for this purpose) are used and the dose has stabilized for 2 months before the start of the study;
  • History of drug or alcohol abuse based on the subject's medical record or self-reported report within 12 months before the screening period;
  • Bototoxin (e. g., Dysport®, ®, Xeomin®, Myobloc®, and JeuveauTM) for the head, face, or neck during the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kaiming Liu contact

86-15068862055

2314411@zju.edu.cn

About this study

Vestibular migraine (VM) is one of the most common vestibular disorders, affecting 1.0% to 2.7% of the general population1, 7% of patients with definite migranous vertigo in dizziness clinics2, as well as 10.3% of VM patients in headache clinics3; 65% to 85% of VM patients are female1. Despite the relative prevalence of vestibular migraine, evidence-based medicine remains scarce. Two Cochrane reviews published in 2023 found that there is almost no evidence to support the use of medications for the acute treatment or preventive treatment of VM4,5.

Calcitonin gene-related peptide (CGRP) has been established as an excellent target for the treatment of migraine. Animal studies suggest a link between CGRP and vestibular disorders. A prospective observational cohort study found that monoclonal antibodies targeting CGRP receptors and ligands were very effective for vestibular migraine (VM), with 90% of participants experiencing at least a 50% reduction in vertigo attacks6. A small-scale prospective randomized controlled trial showed that a monoclonal antibody targeting a CGRP ligand significantly reduced the number of dizziness days per month in VM patients compared to placebo7. The efficacy of CGRP small molecule antagonists for the preventive and acute treatment of migraines has been widely recognized8,9. Therefore, we speculate that Rimegepant is effective for the preventive and acute treatment of vestibular migraine.

Read more

By focusing on a large sample RCT, our study can offer new evidence-based treatment options for patients with vestibular migraine. This is crucial, as many patients with vestibular migraine may not respond well to conventional migraine treatments. Our findings could guide clinicians in choosing more effective therapeutic strategies.

Specifically in acute treatment of vestibular migraine, triptans have failed to show superiority when compared to placebo in treatment vestibular migraine symptoms10. Prochlorperazine, a vestibular sedative, is widely used for acute treatment of vestibular migraine but is known to chronify symptoms11. Should rimegepant demonstrate superiority to placebo in this study, rimegepant could potentially become the first-line treatment for vestibular migraine across the world.

Being tested
Rimegepant, Placebo

What participants receive

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

  • RimegepantDrug

    Take 75mg qd of oral sulfate remigipan orally disintegrating tablets

  • PlaceboDrug

    Take 75mg qd of oral Rimegepan oral tablets with placebo

Study groups in NCT06748664
Study groupRoleWhat they receive
Group A1:Rimegepant ODT 75mg, QDExperimentalNot described
Receives: Drug: Rimegepant
Group A2: Placebo, QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Primary endpoint

    Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 for participants measured daily from the observational phase compared to weeks 12-16.

    Measured: from baseline to weeks 12-16

Secondary outcomes (11)

  1. Secondary objectives for Preventive Treatment Group

    Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 every 4 weeks during the 12-week treatment period compared to baseline

    Measured: every 4 weeks during the 12-week treatment period compared to baseline

  2. Secondary objectives for Preventive Treatment Group

    Change in the number of vestibular symptom attacks every 4 weeks compared to baseline over the 12-week treatment period. (Since VM attacks may recur multiple times within a day, each lasting a short duration, we need to further clearly define what constitutes "one attack.")

    Measured: every 4 weeks compared to baseline over the 12-week treatment period

  3. Secondary objectives for Preventive Treatment Group

    Change in the number of monthly migraine days (MMD) every 4 weeks compared to baseline over the 12-week treatment period

    Measured: every 4 weeks compared to baseline over the 12-week treatment period

  4. Secondary objectives for Preventive Treatment Group

    Change in Migraine Disability Assessment (MIDAS) score from baseline to week 16

    Measured: from baseline to week 16

  5. Secondary objectives for Preventive Treatment Group

    Change in response rate (100%,75%,50%,25%,0%) by percentage reduction in moderate/severe vestibular symptom days from baseline to weeks 12-16

    Measured: from baseline to weeks 12-16

  6. Secondary objectives for Preventive Treatment Group

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

    Measured: from baseline to week 16

  7. Secondary objectives for Preventive Treatment Group

    Change in Vestibular Activities of Daily Living Scale (VADL) score from baseline to week 16

    Measured: from baseline to week 16

  8. Secondary objectives for Preventive Treatment Group

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

    Measured: from baseline to week 16

  9. Secondary objectives for Preventive Treatment Group

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

    Measured: from baseline to week 16

  10. Secondary objectives for Preventive Treatment Group

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

    Measured: from baseline to week 16

  11. Secondary objectives for Preventive Treatment Group

    Change in Migraine-Specific Quality of Life (MSQ) score from baseline to week 16

    Measured: from baseline to 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 posted27 Dec 2024
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 May 2027 (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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748664
Sponsor's protocol ID
2024-0366
Status last verified
Feb 2025
First submitted
19 Dec 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.

    PubMed 31311674

  • Yu S, Kim BK, Guo A, Kim MH, Zhang M, Wang Z, Liu J, Moon HS, Tan G, Yang Q, McGrath D, Hanna M, Stock DA, Gao Y, Croop R, Lu Z. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):476-484. doi: 10.1016/S1474-4422(23)00126-6.

    PubMed 37210098

  • Sharon JD, Krauter R, Chae R, Gardi A, Hum M, Allen I, Levin M. A placebo controlled, randomized clinical trial of galcanezumab for vestibular migraine: The INVESTMENT study. Headache. 2024 Nov-Dec;64(10):1264-1272. doi: 10.1111/head.14835. Epub 2024 Sep 30.

    PubMed 39344988

  • Russo CV, Sacca F, Braca S, Sansone M, Miele A, Stornaiuolo A, De Simone R. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study. Cephalalgia. 2023 Apr;43(4):3331024231161809. doi: 10.1177/03331024231161809.

    PubMed 36946234

  • Webster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.

    PubMed 37042545

  • Webster K, Dor A, Galbraith K, Kassem LH, Harrington-Benton N, Judd O, Kaski D, Maarsingh O, MacKeith S, Ray J, Van Vugt V, Burton M. Pharmacological interventions for prophylaxis of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;2023(4):CD015187. doi: 10.1002/14651858.CD015187.pub2.

    PubMed 37073858

  • Cho SJ, Kim BK, Kim BS, Kim JM, Kim SK, Moon HS, Song TJ, Cha MJ, Park KY, Sohn JH. Vestibular migraine in multicenter neurology clinics according to the appendix criteria in the third beta edition of the International Classification of Headache Disorders. Cephalalgia. 2016 Apr;36(5):454-62. doi: 10.1177/0333102415597890. Epub 2015 Jul 29.

    PubMed 26224714

  • Neuhauser H, Leopold M, von Brevern M, Arnold G, Lempert T. The interrelations of migraine, vertigo, and migrainous vertigo. Neurology. 2001 Feb 27;56(4):436-41. doi: 10.1212/wnl.56.4.436.

    PubMed 11222783

  • Formeister EJ, Rizk HG, Kohn MA, Sharon JD. The Epidemiology of Vestibular Migraine: A Population-based Survey Study. Otol Neurotol. 2018 Sep;39(8):1037-1044. doi: 10.1097/MAO.0000000000001900.

    PubMed 30020261

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rimegepant in people with Vestibular Migraine and Adults 18 Years and Older (no Other Exclusion Criteria), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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 5 inclusion and 13 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 (86-15068862055, 2314411@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint (time frame: from baseline to weeks 12-16). 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 NCT06748664, which also lists 9 linked publications.

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 14 May 2025.

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