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

NCT06748664 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-0366
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Vestibular Migraine; Adults 18 Years and Older (no Other Exclusion Criteria)

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  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 Outcomes (11)

• Secondary objectives for Preventive Treatment Group

  every 4 weeks during the 12-week treatment period compared to baseline

• Secondary objectives for Preventive Treatment Group

  every 4 weeks compared to baseline over the 12-week treatment period

• Secondary objectives for Preventive Treatment Group

  every 4 weeks compared to baseline over the 12-week treatment period

• Secondary objectives for Preventive Treatment Group

  from baseline to week 16

• Secondary objectives for Preventive Treatment Group

  from baseline to weeks 12-16

Study Arms (2)

Group A1:Rimegepant ODT 75mg, QD

EXPERIMENTAL

Drug: Rimegepant

Group A2: Placebo, QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rimegepant DRUG

Take 75mg qd of oral sulfate remigipan orally disintegrating tablets

Group A1:Rimegepant ODT 75mg, QD

Placebo DRUG

Take 75mg qd of oral Rimegepan oral tablets with placebo

Group A2: Placebo, QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Related Publications (9)

• Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.

  PMID: 31311674 BACKGROUND

• Yu S, Kim BK, Guo A, Kim MH, Zhang M, Wang Z, Liu J, Moon HS, Tan G, Yang Q, McGrath D, Hanna M, Stock DA, Gao Y, Croop R, Lu Z. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023 Jun;22(6):476-484. doi: 10.1016/S1474-4422(23)00126-6.

  PMID: 37210098 BACKGROUND

• Sharon JD, Krauter R, Chae R, Gardi A, Hum M, Allen I, Levin M. A placebo controlled, randomized clinical trial of galcanezumab for vestibular migraine: The INVESTMENT study. Headache. 2024 Nov-Dec;64(10):1264-1272. doi: 10.1111/head.14835. Epub 2024 Sep 30.

  PMID: 39344988 BACKGROUND

• Russo CV, Sacca F, Braca S, Sansone M, Miele A, Stornaiuolo A, De Simone R. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study. Cephalalgia. 2023 Apr;43(4):3331024231161809. doi: 10.1177/03331024231161809.

  PMID: 36946234 BACKGROUND

• Webster KE, Dor A, Galbraith K, Haj Kassem L, Harrington-Benton NA, Judd O, Kaski D, Maarsingh OR, MacKeith S, Ray J, Van Vugt VA, Burton MJ. Pharmacological interventions for acute attacks of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;4(4):CD015322. doi: 10.1002/14651858.CD015322.pub2.

  PMID: 37042545 BACKGROUND

• Webster K, Dor A, Galbraith K, Kassem LH, Harrington-Benton N, Judd O, Kaski D, Maarsingh O, MacKeith S, Ray J, Van Vugt V, Burton M. Pharmacological interventions for prophylaxis of vestibular migraine. Cochrane Database Syst Rev. 2023 Apr 12;2023(4):CD015187. doi: 10.1002/14651858.CD015187.pub2.

  PMID: 37073858 BACKGROUND

• Cho SJ, Kim BK, Kim BS, Kim JM, Kim SK, Moon HS, Song TJ, Cha MJ, Park KY, Sohn JH. Vestibular migraine in multicenter neurology clinics according to the appendix criteria in the third beta edition of the International Classification of Headache Disorders. Cephalalgia. 2016 Apr;36(5):454-62. doi: 10.1177/0333102415597890. Epub 2015 Jul 29.

  PMID: 26224714 BACKGROUND

• Neuhauser H, Leopold M, von Brevern M, Arnold G, Lempert T. The interrelations of migraine, vertigo, and migrainous vertigo. Neurology. 2001 Feb 27;56(4):436-41. doi: 10.1212/wnl.56.4.436.

  PMID: 11222783 BACKGROUND

• Formeister EJ, Rizk HG, Kohn MA, Sharon JD. The Epidemiology of Vestibular Migraine: A Population-based Survey Study. Otol Neurotol. 2018 Sep;39(8):1037-1044. doi: 10.1097/MAO.0000000000001900.

  PMID: 30020261 BACKGROUND

MeSH Terms

Interventions

rimegepant sulfate

Central Study Contacts

Kaiming Liu

CONTACT

86-15068862055; 2314411@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share