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Vestibular MigrainePhase 2NCT06992674

The R-E-V-I-V-A-L Study

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

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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
Conditions the study is for
Vestibular Migraine
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
1 siteChina
Study dates
1 Jun 2025to 1 Dec 2026
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

  • 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 treatment with a CGRP medication
  • Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets.
  • Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during the study participation
Show all 14Show fewer
  • 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
  • Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start
  • Other conditions judged by the investigator as unsuitable for inclusion

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Placebo Controlled, National, Multi-center, Randomized Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: The REVIVAL 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 placebo

Study groups in NCT06992674
Study groupRoleWhat they receive
Group A1:Rimegepant ODT 75mg, EODExperimentalNot 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. Moderate/Severe vestibular symptom days

    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. Moderate/Severe vestibular symptom days

    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. the number of vestibular symptom attacks

    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. MMD

    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. MIDAS

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

    Measured: from baseline to week 16

  5. percentage reduction in moderate/severe vestibular symptom days

    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. DHI

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

    Measured: from baseline to week 16

  7. VADL

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

    Measured: from baseline to week 16

  8. PHQ-9

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

    Measured: from baseline to week 16

  9. GAD-7

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

    Measured: from baseline to week 16

  10. PGIC

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

    Measured: from baseline to week 16

  11. MSQ

    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 posted28 May 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2026 (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
NCT06992674
Sponsor's protocol ID
2025-0124
Status last verified
Apr 2025
First submitted
9 May 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
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, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate/Severe vestibular symptom days (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 NCT06992674, 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 25 Jun 2025.

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