An observational study in Vestibular Migraine, Dizziness and Vertigo, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 126 across 44 observational studies indexed under Dizziness.
Browse Dizziness studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will recruit male and female participants aged 18 to 75 years in China, who have vestibular migraine diagnosed according to the VM definition published by the Bárány Society in 2012. Participants must be prescribed with CGRP class drugs based on the clinical judgment of the physician and the willingness of the participants. Participants in Groups A1 and B1 will be considered for screening for eligibility criteria only after being prescribed with CGRP class drugs. Participants in Groups A2 and B2 will be considered for screening for eligibility criteria only after being prescribed with non-CGRP class drugs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Understanding and compliance with the study procedures and methods, voluntary participation in this trial, and written .
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A is the acute treatment group, which will observe the effectiveness of medication used for acute treatment after a VM (Vestibular Migraine) attack in the participants. Subgroup A1 will include participants who undergo acute treatment with CGRP-targeted drugs.
Drug: CGRP R Inhibitor; CGRP Inhibitor
Group A is the acute treatment group, which will observe the effectiveness of medication used for acute treatment after a VM (Vestibular Migraine) attack in the participants. Subgroup A2 will include participants who undergo acute treatment with medications other than CGRP drugs (such as NSAIDs, triptans, etc.).
Drug: none-CGRP
Group B is the preventive treatment group, which will observe the efficacy of 12-week prophylactic medication in participants. Subgroup B1: Patients receiving CGRP-targeted drugs (e.g., CGRP monoclonal antibodies or gepants) for preventive treatment.
Drug: CGRP R Inhibitor; CGRP Inhibitor
Group B is the preventive treatment group, which will observe the efficacy of 12-week prophylactic medication in participants. Subgroup B2: Patients receiving non-CGRP preventive medications (e.g., flunarizine, topiramate, propranolol, etc.).
Drug: none-CGRP
Participants who are prescribed CGRP class drugs for the acute treatment of VM will be considered for inclusion in Group A1.Participants who are prescribed CGRP class drugs for the preventive treatment of VM will be considered for inclusion in Group B1.
Participants who are prescribed none-CGRP class drugs for the acute treatment of VM will be considered for inclusion in Group A2.Participants who are prescribed none-CGRP class drugs for the preventive treatment of VM will be considered for inclusion in Group B2.
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
Vestibular symptom severity post-dose will be measured on Visual Analogue Scale (VAS) (0=No vestibular symptom, 10=worst vestibular symptom).
Time frame: within 48 hours post-dose of CGRP medication
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
After the start of treatment, participants are required to keep a daily dizziness diary. The definition of moderate and severe vestibular symptoms refers to the Barany Society. Symptoms that have an impact on daily activities but can still be endured are defined as moderate, while symptoms that completely prevent daily activities from being carried out are defined as severe.
Time frame: 12 weeks after treatment
The percentage of patients satisfied with medication to evaluate the effectiveness of different treatment in the treatment of VM
Satisfaction with medication will be measured via 7-point SM scale
Time frame: Within 48 hours post-dose of medication for group A1 and A2, 12-weeks after treatment for group B1 and B2
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Dec 2027, 24 months later.
Of 17 observational studies under Dizziness, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →