Rimegepant para el tratamiento preventivo de la migraña vestibular

Fecha de inicio: 1 de junio de 2025

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