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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Rimegepant to see if it can help people with vestibular migraine, a type of migraine that causes dizziness and balance issues. Vestibular migraines affect a significant number of people, particularly women, but there aren’t many effective treatments available. The goal of this trial is to find out if Rimegepant can reduce the frequency and severity of symptoms for those suffering from this condition.

To participate in the trial, you need to be between 18 and 75 years old and have been diagnosed with vestibular migraine. You should experience at least four days of dizziness per month. If you qualify and choose to participate, you will receive either Rimegepant or a placebo (a treatment with no active medication) and be monitored for your symptoms. This study could potentially lead to better treatment options for vestibular migraine, offering hope to many who currently struggle with this condition. If Rimegepant proves to be effective, it could become a leading treatment worldwide.

Gender

ALL

Eligibility 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:
• • 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.