Chinese Real-world Study of Treatment of Vestibular Migraine

Korábbi kezelés

• More than two preventive migraine medications have failed.
• Previous or current treatment with CGRP class drugs.
• Acceptable if using no more than two migraine preventive medications (prescribed specifically for this purpose), with stable dosing for at least 2 months prior to study start.
• History of drug or alcohol abuse within the 12 months prior to screening, based on the participant's medical records or self-report.
• Those who have received or plan to receive botulinum toxin (e.g., Dysport®, Botox®, Xeomin®, Myobloc®, Jeuveau™) for therapeutic or cosmetic purposes in the head, face, or neck within 4 months prior to screening or during the study period.

Más betegség

• Presence of a condition or abnormality that the investigator believes would affect the safety of the patient or the quality of the data.
• History of ear surgery (excluding ear tube surgery).
• Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo, BPPV). This includes Ménière'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 seasickness.
• History of serious medical or psychiatric conditions, as judged by the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, renal disease, liver disease, Raynaud's disease, uncontrolled psychiatric illness, or past psychiatric hospitalization).
• History of mania, psychosis, or suicidal ideation.

Egyéb

• Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during study participation.

• Male or female, aged between 18 and 75 years.
• Meet the following criteria established by the Barany Society for the diagnosis of vestibular migraine or probable vestibular migraine:
  • Vestibular Migraine A: At least five episodes with moderate or severe vestibular symptoms lasting from 5 minutes to 72 hours.
  • B: Current or past history of migraine, with or without aura, according to the International Classification of Headache Disorders (ICHD-3).
  • C: One or more migraine features during at least 50% of vestibular episodes:
  • Headache with at least two of the following characteristics: unilateral, pulsating, moderate or severe pain, worsening with routine physical activity.
  • Photophobia and phonophobia. Visual aura. D: Not better accounted for by another vestibular or ICHD diagnosis. Probable Vestibular Migraine A. At least five episodes with moderate or severe vestibular symptoms lasting from 5 minutes to 72 hours.
  • Meets only one of the criteria B or C for vestibular migraine (history of migraine or migraine features during episodes).
  • Not better accounted for by another vestibular or ICHD diagnosis.
• More than or equal to 4 days per month with confirmed vestibular symptom in the three months prior to enrollment (only required for group B).
• Able to complete at least 80% of the electronic diary during the treatment period.
• The investigator believes that the participant is able to read, understand, and complete the study questionnaires and headache diary.
  • Understanding and compliance with the study procedures and methods, voluntary participation in this trial, and written informed consent.