A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

May 9, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Vestibular migraine (VM) is one of the most common vestibular disorders, affecting 1.0% to 2.7% of the general population1, 7% of patients with definite migranous vertigo in dizziness clinics2, as well as 10.3% of VM patients in headache clinics3; 65% to 85% of VM patients are female1. Despite the relative prevalence of vestibular migraine, evidence-based medicine remains scarce. Two Cochrane reviews published in 2023 found that there is almost no evidence to support the use of medications for the acute treatment or preventive treatment of VM4,5.

Calcitonin gene-related peptide (CGRP) has been established as an excellent target for the treatment of migraine. Animal studies suggest a link between CGRP and vestibular disorders. A prospective observational cohort study found that monoclonal antibodies targeting CGRP receptors and ligands were very effective for vestibular migraine (VM), with 90% of participants experiencing at least a 50% reduction in vertigo attacks6. A small-scale prospective randomized controlled trial showed that a monoclonal antibody targeting a CGRP ligand significantly reduced the number of dizziness days per month in VM patients compared to placebo7. The efficacy of CGRP small molecule antagonists for the preventive and acute treatment of migraines has been widely recognized8,9. Therefore, we speculate that Rimegepant is effective for the preventive and acute treatment of vestibular migraine.

By focusing on a large sample RCT, our study can offer new evidence-based treatment options for patients with vestibular migraine. This is crucial, as many patients with vestibular migraine may not respond well to conventional migraine treatments. Our findings could guide clinicians in choosing more effective therapeutic strategies.

Specifically in acute treatment of vestibular migraine, triptans have failed to show superiority when compared to placebo in treatment vestibular migraine symptoms10. Prochlorperazine, a vestibular sedative, is widely used for acute treatment of vestibular migraine but is known to chronify symptoms11. Should rimegepant demonstrate superiority to placebo in this study, rimegepant could potentially become the first-line treatment for vestibular migraine across the world.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged 18 to 75 years
  • Documentation of a VM diagnosis according to the Barany Society/ ICHD-31

  • More than 4 definite dizzy days per month in the 3 months prior to screen

    ≥1 prior preventive treatment failure

  • E-diary compliance ≥ 80% during observational phase

Exclusion Criteria:

  • Pregnant women, lactating women, or reluctance to use approved contraception during study participation;
  • There is a condition or abnormality that the investigator believes will affect the safety of the patients or the quality of the data;
  • Allergic to the ingredients of Remeipine sulfate or sulfate;
  • Previous treatment with remejepam;
  • History of ear surgery (except for ear tube surgery);
  • Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo BPPV). Including Meniere's disease, superior semicircular canal prolapse syndrome, vestibular neuritis, persistent postural perceptual vertigo, unilateral or bilateral loss of vestibular function, cerebellar or brainstem disease, multiple sclerosis or sea sickness;
  • Failure of more than 2 preventive migraine drugs;
  • Previous or current treatment with CGRP drugs;
  • History of serious medical or mental illness (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, Raynaud's disease, uncontrollable mental illness, or past psychiatric hospitalization, at the discretion of the treating physician);
  • A history of mania, psychosis, or suicidal ideation;
  • Acceptable if no more than two drugs for migraine prevention (prescribed specifically for this purpose) are used and the dose has stabilized for 2 months before the start of the study;
  • History of drug or alcohol abuse based on the subject's medical record or self-reported report within 12 months before the screening period;
  • Bototoxin (e. g., Dysport®, ®, Xeomin®, Myobloc®, and JeuveauTM) for the head, face, or neck during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A1:Rimegepant ODT 75mg, QD
Drug: Rimegepant
Take 75mg qd of oral sulfate remigipan orally disintegrating tablets
Placebo Comparator: Group A2: Placebo, QD
Drug: Placebo
Take 75mg qd of oral Rimegepan oral tablets with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: from baseline to weeks 12-16
Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 for participants measured daily from the observational phase compared to weeks 12-16.
from baseline to weeks 12-16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in dizziness handicap inventory (DHI) score from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: every 4 weeks during the 12-week treatment period compared to baseline
Change in number of Moderate/Severe vestibular symptom days as defined by Barany Society1 every 4 weeks during the 12-week treatment period compared to baseline
every 4 weeks during the 12-week treatment period compared to baseline
Secondary objectives for Preventive Treatment Group
Time Frame: every 4 weeks compared to baseline over the 12-week treatment period
Change in the number of vestibular symptom attacks every 4 weeks compared to baseline over the 12-week treatment period. (Since VM attacks may recur multiple times within a day, each lasting a short duration, we need to further clearly define what constitutes "one attack.")
every 4 weeks compared to baseline over the 12-week treatment period
Secondary objectives for Preventive Treatment Group
Time Frame: every 4 weeks compared to baseline over the 12-week treatment period
Change in the number of monthly migraine days (MMD) every 4 weeks compared to baseline over the 12-week treatment period
every 4 weeks compared to baseline over the 12-week treatment period
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in Migraine Disability Assessment (MIDAS) score from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to weeks 12-16
Change in response rate (100%,75%,50%,25%,0%) by percentage reduction in moderate/severe vestibular symptom days from baseline to weeks 12-16
from baseline to weeks 12-16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in Vestibular Activities of Daily Living Scale (VADL) score from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in General Anxiety Disorder-7 (GAD-7) score from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in Patient Global Impression of Change（PGIC scale）from baseline to week 16
from baseline to week 16
Secondary objectives for Preventive Treatment Group
Time Frame: from baseline to week 16
Change in Migraine-Specific Quality of Life (MSQ) score from baseline to week 16
from baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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