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Not yet recruitingNCT07435090Updated Feb 27, 2026

Efficacy and Safety of Rimegepant for Acute Dizziness

A Phase 2/3 interventional study of Rimegepant 75mg Orally Disintegrating Tablets (ODT) and Betahistine Mesylate tablet in Dizziness, sponsored by Shi Tianming. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Shi Tianming · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dizziness

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03

In context

Dizziness

226 studies on the registry are indexed under Dizziness; 56 are open to participants now.

This study's planned enrollment of 370 is above the median of 43 across 170 interventional studies indexed under Dizziness.

Browse Dizziness studies →

Lead sponsor

This is the only study on the registry with Shi Tianming as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 18 and 65 years;
  2. 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;
  3. The patient has experienced at least 3 similar dizziness attacks in the past, with each attack lasting more than 2 hours;
  4. 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);
  5. The patient has completed emergency laboratory examination and imaging evaluation to preliminarily rule out dizziness attacks caused by other reasons;
  6. The patient can sign an form.

Exclusion criteria

Exclusion Criteria:

  1. New focal neurological signs;
  2. History of previous stroke or ;
  3. ABCD2 score ≥ 4 points;
  4. Presence of other vestibular peripheral vertigo disorders, such as benign paroxysmal positional vertigo, Meniere's disease, vestibular neuritis, sudden deafness, etc.;
  5. Unexplained hearing abnormalities;
  6. History of serious internal medical or mental illnesses, such as coronary heart disease (acute coronary syndrome), severe heart failure ( Functional Classification class II or above), severe arrhythmia (such as severe bradycardia, third-degree atrioventricular block, ventricular tachycardia, etc.), severe liver dysfunction ( or aspartate aminotransferase exceeding three times the ), 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;
  7. Pregnant or breastfeeding women;
  8. Self-administered vestibular inhibitors or CGRP drugs after the dizziness attack;
  9. History of intolerance or allergy to rimegepant use;
  10. Anticipated inability to comply with research requirements.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
370 participants (estimated)

Study arms

  • Experimental
    Rimegepant group

    Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)

  • Active comparator
    Control group

    Drug: Betahistine Mesylate tablet

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2026; primary completion for Dec 2027, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 25, 2025
First posted
Feb 27, 2026
StartEst.
Mar 20, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07435090
Lead sponsor
Shi Tianming
Responsible party
Shi Tianming (Associate Chief Physician, Zhejiang Provincial People's Hospital) — Sponsor-investigator
First posted
Feb 27, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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