Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07435090

Efficacy and Safety of Rimegepant for 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

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 tablet

Drug

A single dose of betahistine mesylate (12 mg) administered orally.

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.

Sponsors and collaborators

Lead sponsor

Shi Tianming

Other

Registry information

Official study title

A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Rimegepant in the Treatment of Acute Dizziness

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.