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
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.