Vestibular MigraineNCT07203248
Chinese Real-world Study of Treatment of Vestibular Migraine
An observational study of Vestibular Migraine and Dizziness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Migraine, Dizziness, Vertigo
- What is being tested?
- CGRP R Inhibitor; CGRP Inhibitor and none-CGRP
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2028
- How long will I take part?
- 12 Weeks
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-world Study on the Use of CGRP-targeted Medications for the Treatment of Vestibular Migraine in Chinese Patients
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.
- Conditions
- Vestibular Migraine, Dizziness, Vertigo
- Being tested
- CGRP R Inhibitor; CGRP Inhibitor, none-CGRP
- Keywords
- Vestibular Migraine, CGRP, acute treatment, preventive treatment, real-world
- Medical subject headings
- Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGRP R Inhibitor; CGRP InhibitorDrug
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.
none-CGRPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A1 | 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. Receives: Drug: CGRP R Inhibitor; CGRP Inhibitor | |
| A2 | 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.). Receives: Drug: none-CGRP | |
| B1 | 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. Receives: Drug: CGRP R Inhibitor; CGRP Inhibitor | |
| B2 | 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.). Receives: Drug: none-CGRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12 weeks after treatment
Secondary outcomes (1)
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
Measured: Within 48 hours post-dose of medication for group A1 and A2, 12-weeks after treatment for group B1 and B2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Hangzhou, Sir Run Run Shaw Hospital, Affiliated Hospital of Jiaxing University, The People's Hospital of Quzhou, The First People Hospital of Hangzhou Lin An District, Shaoxing People's Hospital, Jiaxing Hospital of Traditional Chinese Medicine, Hangzhou Hospital of Traditional Chinese Medicine, Affiliated Wenling Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhongshan Hospital Of Traditional Chinese Medicine, The First People's Hospital of Huzhou, Xin Hua Hospital of Zhejiang Province, The Affiliated Hospital of Hangzhou Normal University, Huzhou Central Hospital, Chinese Medical University, Tiantai County People's Hospital, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203248
- Sponsor's protocol ID
- 20250455
- Status last verified
- Jul 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No