Status:
NOT_YET_RECRUITING
Chinese Real-world Study of Treatment of Vestibular Migraine
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
First People's Hospital of Hangzhou
Sir Run Run Shaw Hospital
Conditions:
Vestibular Migraine
Dizziness
Eligibility:
All Genders
18-75 years
Brief Summary
Vestibular migraine is a phenotype of migraine, characterized by more prominent vertigo symptoms compared to headache. Treatments for VM are mainly divided into two categories: acute treatment and pre...
Eligibility Criteria
Inclusion
- 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.
- B. Meets only one of the criteria B or C for vestibular migraine (history of migraine or migraine features during episodes).
- C. 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.
Exclusion
- Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during study participation.
- 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.
- More than two preventive migraine medications have failed.
- Previous or current treatment with CGRP class drugs.
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07203248
Start Date
December 1 2025
End Date
December 1 2028
Last Update
October 2 2025
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