Rimegepant for Preventive Treatment of Vestibular Migraine
Rimegepant
+ Placebo
Prevention Study
Summary
Study start date: June 1, 2025
Actual date on which the first participant was enrolled.This study is investigating whether a drug called Rimegepant can effectively treat vestibular migraine, a condition that causes dizziness and vertigo in people who also experience migraines. Vestibular migraines are quite common, especially among women, but there are not many proven treatments available. Researchers believe that Rimegepant, which targets specific proteins involved in migraines, might help reduce the symptoms of vestibular migraine. This research is important because it may lead to better treatment options for people who do not benefit from current medications. In the study, participants with vestibular migraine will be randomly assigned to receive either Rimegepant or a placebo. Rimegepant is given as a pill taken orally. The trial aims to see if Rimegepant can reduce the frequency and severity of vertigo attacks compared to a placebo. This study does not mention specific risks or benefits, but the goal is to determine if Rimegepant can become a first-line treatment for vestibular migraine, offering a new option for those affected by this condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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: * Vestibular hypofunction (unilateral or bilateral) * History of ear surgery (other than ear tubes) * Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo (BPPV)), including Meniere's disease, superior semicircular canal dehiscence syndrome, vestibular neuritis, persistent postural-perceptual dizziness, unilateral or bilateral vestibular hypofunction, cerebellar or brainstem disorders, multiple sclerosis, or motion sickness. * Prior or current treatment with a CGRP medication * Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets. * Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during the study participation * History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, and uncontrolled psychiatric disease or past psychiatric hospitalization) * A history of severe medical or psychiatric conditions (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, renal disease, liver disease, Raynaud's disease, uncontrolled psychiatric disorders, or previous psychiatric hospitalizations) as determined by the treating physician * A history of mania, psychosis, or suicidal ideation * A history of drug or alcohol abuse within the 12 months prior to screening, based on the subject's medical records or self-report * Individuals who have received head, face, or neck botulinum toxin injections (such as Dysport®, Botox®, Xeomin®, Myobloc®, and JeuveauTM) within 4 months before screening or are scheduled for such injections during the study period * Unwilling to use approved form of birth control during the study * Ok if on up to 2 migraine prophylactic medications (prescribed for that purpose), dose must be stable for 2 months prior to study start * Other conditions judged by the investigator as unsuitable for inclusion
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road
Hangzhou, ChinaOpen Department of Neurology, The Second Affiliated Hospital, Zhejiang University School of Medicine, No.88 Jiefang Road in Google Maps