DizzinessPhase 2/3NCT07435090
Efficacy and Safety of Rimegepant for Acute Dizziness
A Phase 2/3 study testing Rimegepant 75mg Orally Disintegrating Tablets (ODT) and Betahistine Mesylate tablet in people with Dizziness, run by Shi Tianming.
Trial summary
This study aims to explore the efficacy and safety of rimegepant for acute dizziness, including vestibular migraine (VM) and benign recurrent vertigo (BRV), through a multicenter, randomized controlled clinical trial. This study addresses the urgent clinical need for effective therapies for acute dizziness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dizziness
- What is being tested?
- Rimegepant 75mg Orally Disintegrating Tablets (ODT) and Betahistine Mesylate tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 30 Jun 2028
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years;
- Spontaneous dizziness without cochlear symptoms, with moderate or severe symptom intensity. The severity of dizziness is assessed based on the Vertigo or Dizziness Visual Analog Scale (VAS) score, and this study included patients with dizziness exceeding 4 points on the VAS score;
- The patient has experienced at least 3 similar dizziness attacks in the past, with each attack lasting more than 2 hours;
- The accompanying symptoms or related medical history during the attack period meet any of the following criteria: 1) Migraine-like headache (unilateral, pulsatile, moderate to severe, aggravated by activity; at least 2 items); 2) Photophobia and phonophobia; 3) Nausea or vomiting; 4) Visual aura; 5) Nystagmus; 6) The patient has a personal history of migraine; 7) Severe kinetosis; 8) Family history of migraine; 9) Typical triggering factors for migraine (menstrual period, alcohol consumption, sleep disturbances);
- The patient has completed emergency laboratory examination and imaging evaluation to preliminarily rule out dizziness attacks caused by other reasons;
- The patient can sign an informed consent form.
Who cannot join
- New focal neurological signs;
- History of previous stroke or transient ischemic attack;
- ABCD2 score ≥ 4 points;
- Presence of other vestibular peripheral vertigo disorders, such as benign paroxysmal positional vertigo, Meniere's disease, vestibular neuritis, sudden deafness, etc.;
- Unexplained hearing abnormalities;
- History of serious internal medical or mental illnesses, such as coronary heart disease (acute coronary syndrome), severe heart failure (New York Heart Association Functional Classification class II or above), severe arrhythmia (such as severe bradycardia, third-degree atrioventricular block, ventricular tachycardia, etc.), severe liver dysfunction (alanine aminotransferase or aspartate aminotransferase exceeding three times the upper limit of normal), severe renal dysfunction (serum creatinine level exceeding twice the upper limit of normal), uncontrolled severe hypertension (blood pressure above 180/120 mmHg), active malignant tumors, and uncontrolled mental illness;
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- Pregnant or breastfeeding women;
- Self-administered vestibular inhibitors or CGRP drugs after the dizziness attack;
- History of intolerance or allergy to rimegepant use;
- Anticipated inability to comply with research requirements.
About this study
Official title: A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Rimegepant in the Treatment of Acute Dizziness
This study aims to explore the efficacy and safety of rimegepant for acute dizziness, including vestibular migraine (VM) and benign recurrent vertigo (BRV), through a multicenter, randomized controlled clinical trial. This study addresses the urgent clinical need for effective therapies for acute dizziness. Additionally, we will dynamically observe the changes in calcitonin gene-related peptide (CGRP) levels before and after treatment and explore the predictive value of CGRP levels for treatment efficacy and the prognosis of recurrence in patients. This study aims to provide a scientific basis to improve clinical management strategies for acute dizziness.
- Conditions
- Dizziness
- Being tested
- Rimegepant 75mg Orally Disintegrating Tablets (ODT), Betahistine Mesylate tablet
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75mg Orally Disintegrating Tablets (ODT)Drug
A single dose of Rimegepant orally disintegrating tablets (75 mg) combined with betahistine mesylate (12 mg) administered orally.
Betahistine Mesylate tabletDrug
A single dose of betahistine mesylate (12 mg) administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant group | Experimental | Not described Receives: Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT) |
| Control group | Active comparator | Not described Receives: Drug: Betahistine Mesylate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients whose dizziness symptoms decreased from moderate or severe to none or mild after 1 hour of administration.
Measured: 1 hour after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Tianming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Tianming, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435090
- Sponsor's protocol ID
- RECOVER
- Status last verified
- Feb 2026
- First submitted
- 25 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Rimegepant in the Treatment of Acute Dizziness
- ClinicalTrials.gov ID
- NCT07435090
- Acronym / sponsor ID
- RECOVER
- Conditions
- Dizziness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Shi TianmingUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Feb 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.
This study aims to explore the efficacy and safety of rimegepant for acute dizziness, including vestibular migraine (VM) and benign recurrent vertigo (BRV), through a multicenter, randomized controlled clinical trial. This study addresses the urgent clinical need for effective therapies for acute dizziness. Additionally, we will dynamically observe the changes in calcitonin gene-related peptide (CGRP) levels before and after treatment and explore the predictive value of CGRP levels for treatment efficacy and the prognosis of recurrence in patients. This study aims to provide a scientific basis to improve clinical management strategies for acute dizziness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimegepant group | Experimental | Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT) |
| Control group | Active comparator | Drug: Betahistine Mesylate tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 65 years;
- Spontaneous dizziness without cochlear symptoms, with moderate or severe symptom intensity. The severity of dizziness is assessed based on the Vertigo or Dizziness Visual Analog Scale (VAS) score, and this study included patients with dizziness exceeding 4 points on the VAS score;
- The patient has experienced at least 3 similar dizziness attacks in the past, with each attack lasting more than 2 hours;
- The accompanying symptoms or related medical history during the attack period meet any of the following criteria: 1) Migraine-like headache (unilateral, pulsatile, moderate to severe, aggravated by activity; at least 2 items); 2) Photophobia and phonophobia; 3) Nausea or vomiting; 4) Visual aura; 5) Nystagmus; 6) The patient has a personal history of migraine; 7) Severe kinetosis; 8) Family history of migraine; 9) Typical triggering factors for migraine (menstrual period, alcohol consumption, sleep disturbances);
- The patient has completed emergency laboratory examination and imaging evaluation to preliminarily rule out dizziness attacks caused by other reasons;
Key exclusion criteria (10 listed)
- New focal neurological signs;
- History of previous stroke or transient ischemic attack;
- ABCD2 score ≥ 4 points;
- Presence of other vestibular peripheral vertigo disorders, such as benign paroxysmal positional vertigo, Meniere's disease, vestibular neuritis, sudden deafness, etc.;
- Unexplained hearing abnormalities;
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 |
|---|---|---|
| Rimegepant 75mg Orally Disintegrating Tablets (ODT)A single dose of Rimegepant orally disintegrating tablets (75 mg) combined with betahistine mesylate (12 mg) administered orally. | Drug | Rimegepant group |
| Betahistine Mesylate tabletA single dose of betahistine mesylate (12 mg) administered orally. | Drug | Control group |
Primary outcome
The proportion of patients whose dizziness symptoms decreased from moderate or severe to none or mild after 1 hour of administration.
Time frame: 1 hour after drug administration.
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 27 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rimegepant 75mg Orally Disintegrating Tablets (ODT) and Betahistine Mesylate tablet in people with Dizziness, run by Shi Tianming.
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 6 inclusion and 10 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 27 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The proportion of patients whose dizziness symptoms decreased from moderate or severe to none or mild after 1 hour of administration. (time frame: 1 hour after drug administration.). 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 27 Feb 2026.