Chinese Real-world Study of Treatment of Vestibular Migraine (NCT07203248) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chinese Real-world Study of Treatment of Vestibular Migraine
2,000 participantsStarted 2025-12
Plain-language 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 preventive treatment. Acute treatment aims to reduce the severity and duration of a single episode, while preventive treatment aims to decrease the frequency, severity, and duration of attacks. Current acute treatments are primarily divided into pain relief and anti-dizziness, with specific drugs such as triptans and ergots being applicable for pain relief, but only betahistine has weak evidence for anti-dizziness, and relevant clinical evidence is very scarce. Preventive treatment mainly refers to migraine preventive treatments, with recommended medications including traditional drugs like topiramate, flunarizine, propranolol, etc., but the efficacy and safety of these drugs are limited. CGRP-targeted drugs are believed to play a role in the preventive treatment of VM, and there are related literature reports, but most are small-sample studies or retrospective studies. This study aims to explore the real-world efficacy of CGRP-targeted drugs in the acute and preventive treatment of VM through a prospective real-world study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
The average scores of the most severe vestibular symptom post-dose measured by VAS scale to evaluate the effectiveness of CGRP medication in the acute treatment of vestibular migraine
Timeframe: within 48 hours post-dose of CGRP medication
2
Change in number of Moderate/Severe vestibular symptom days as defined by Bárány Society for participants measured daily from the observational phase compared to baseline between group B1 and B2
Timeframe: 12 weeks after treatment
Trial details
NCT IDNCT07203248
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. 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.