Vestibular MigrainePhase 4VM-rimeNCT07871097
Acute Treatment of Vestibular Migraine by Rimegepant
A Phase 4 study of Vestibular Migraine, run by Wensheng Qu at 1 site in China.
Trial summary
To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vestibular Migraine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years, male or female.
- Diagnosis of vestibular migraine according to the Bárány Society criteria.
- ≥4 episodes of characteristic vestibular symptoms in the past year, each of moderate to severe intensity and lasting >2 hours (without intervention).
- Signed informed consent obtained from the participant.
Who cannot join
- Presence of other disorders causing acute vestibular symptoms (e.g., Ménière's disease, otitis media).
- Coexisting non-vertiginous dizziness (e.g., dizziness due to panic disorder), unless the patient can clearly distinguish these episodes from vestibular-migraine attacks.
- Severe hepatic dysfunction (ALT and/or AST >3× upper limit of normal) or renal impairment (creatinine clearance <30 mL/min).
- Severe cardiovascular or cerebrovascular disease.
- Alcohol abuse or substance abuse.
- Known pregnancy or lactation, or a positive pregnancy test prior to randomization.
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- Contraindication or hypersensitivity to any medications used in the study.
- Initiation or dose adjustment of any preventive migraine therapy within 3 months prior to study drug administration.
- Use of any other anti-vertigo or analgesic medication within 6 hours before study drug administration.
- Participation in another interventional clinical study that could affect outcome assessment.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study or poses significant risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430040
Wensheng Qu, 18971622660, qws0309@163.com
About this study
Official title: Efficacy of Rimegepant in the Treatment of Acute Vestibular Migraine -- Multicenter, Prospective, Cross-design, Randomized, Placebo-controlled Study
To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.
- Conditions
- Vestibular Migraine
- Being tested
- First dose rimegepant, second dose placebo, First dose placebo, second dose rimegepant
- Keywords
- remigepant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First dose rimegepant, second dose placeboDrug
First dose rimegepant, second dose placebo
First dose placebo, second dose rimegepantDrug
First dose placebo, second dose rimegepant
| Study group | Role | What they receive |
|---|---|---|
| First dose rimegepant, second dose placebo | Experimental | First dose rimegepant, second dose placebo Receives: Drug: First dose rimegepant, second dose placebo; Drug: First dose placebo, second dose rimegepant |
| First dose placebo, second dose rimegepant | Experimental | First dose placebo, second dose rimegepant Receives: Drug: First dose rimegepant, second dose placebo; Drug: First dose placebo, second dose rimegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo symptom relief rate
After 2 hours of medication, vertigo symptoms improved from moderate or severe to mild or no vertigo.
Measured: 2 hours after medication
Secondary outcomes (3)
headache relief rate
After 2 hours of medication, headache symptoms improved from moderate or severe to mild or no vertigo
Measured: 2 hours after medication
relief rate of nausea and vomiting
After 2 hours of medication, complete resolution rate of nausea and vomiting
Measured: 2 hours after medication
relief rate of photophobia and phonophobia
After 2 hours of medication, complete resolution rate of photophobia and phonophobia
Measured: 2 hours after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wensheng Qu
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan No.1 Hospital, Wuhan Puren Hospital, Xiangyang Central Hospital, Xinyang Central Hospital
- Responsible party
- Sponsor-investigator, Wensheng Qu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871097
- Sponsor's protocol ID
- 20250827
- Acronym
- VM-rime
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared, including demographic characteristics (e.g., age and sex), baseline clinical characteristics, migraine-related efficacy outcomes (e.g., migraine frequency, pain freedom, and symptom relief), and safety data (e.g., adverse events and laboratory results). The final analyzable dataset used for statistical analyses will also be provided.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rimegepant in the Treatment of Acute Vestibular Migraine -- Multicenter, Prospective, Cross-design, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07871097
- Acronym / sponsor ID
- VM-rime / 20250827
- Conditions
- Vestibular Migraine
- Keywords
- remigepant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wensheng QuUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan No.1 Hospital, Wuhan Puren Hospital, Xiangyang Central Hospital, Xinyang Central Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First dose rimegepant, second dose placebo | Experimental | Drug: First dose rimegepant, second dose placebo, Drug: First dose placebo, second dose rimegepantFirst dose rimegepant, second dose placebo |
| First dose placebo, second dose rimegepant | Experimental | Drug: First dose rimegepant, second dose placebo, Drug: First dose placebo, second dose rimegepantFirst dose placebo, second dose rimegepant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years, male or female.
- Diagnosis of vestibular migraine according to the Bárány Society criteria.
- ≥4 episodes of characteristic vestibular symptoms in the past year, each of moderate to severe intensity and lasting >2 hours (without intervention).
- Signed informed consent obtained from the participant.
Key exclusion criteria (11 listed)
- Presence of other disorders causing acute vestibular symptoms (e.g., Ménière's disease, otitis media).
- Coexisting non-vertiginous dizziness (e.g., dizziness due to panic disorder), unless the patient can clearly distinguish these episodes from vestibular-migraine attacks.
- Severe hepatic dysfunction (ALT and/or AST >3× upper limit of normal) or renal impairment (creatinine clearance <30 mL/min).
- Severe cardiovascular or cerebrovascular disease.
- Alcohol abuse or substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First dose rimegepant, second dose placeboFirst dose rimegepant, second dose placebo | Drug | First dose placebo, second dose rimegepant, First dose rimegepant, second dose placebo |
| First dose placebo, second dose rimegepantFirst dose placebo, second dose rimegepant | Drug | First dose placebo, second dose rimegepant, First dose rimegepant, second dose placebo |
Primary outcome
Vertigo symptom relief rate
Time frame: 2 hours after medication
After 2 hours of medication, vertigo symptoms improved from moderate or severe to mild or no vertigo.
3 secondary outcomes
headache relief rate
Time frame: 2 hours after medication
relief rate of nausea and vomiting
Time frame: 2 hours after medication
relief rate of photophobia and phonophobia
Time frame: 2 hours after medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared, including demographic characteristics (e.g., age and sex), baseline clinical characteristics, migraine-related efficacy outcomes (e.g., migraine frequency, pain freedom, and symptom relief), and safety data (e.g., adverse events and laboratory results). The final analyzable dataset used for statistical analyses will also be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Vestibular Migraine, run by Wensheng Qu 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Oct 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Wensheng Qu (18971622660, qws0309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertigo symptom relief rate (time frame: 2 hours after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.