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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rimegepant 75mg Orally Disintegrating Tablets (ODT)
DrugA single dose of Rimegepant orally disintegrating tablets (75 mg) combined with betahistine mesylate (12 mg) administered orally.
Betahistine Mesylate tablet
DrugA single dose of betahistine mesylate (12 mg) administered orally.
Treatment groups
370 Participants
are divided into 2 treatment groupsGroup A: Rimegepant groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shi Tianming
Lead sponsor
Zhejiang Provincial People's Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: