Efficacy and Safety of Rimegepant for Acute Dizziness

ConditionDizziness
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShi Tianming

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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.;

Trial design

Treatments tested in this trial

  • Rimegepant 75mg Orally Disintegrating Tablets (ODT)
  • Betahistine Mesylate tablet

Treatment groups

370 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Shi Tianming

Lead sponsor

Zhejiang Provincial People's Hospital

Sponsor institution