Chinese Real-world Study of Treatment of Vestibular Migraine

Zhejiang University

Status: Not yet enrolling

Conditions: Vertigo; Vestibular Migraine; Dizziness

Treatments: Drug: CGRP R Inhibitor; CGRP Inhibitor; Drug: none-CGRP

Study type: Observational

Funder types: Other

Identifiers

NCT07203248

20250455

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, aged between 18 and 75 years.

2. 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.

3. 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).

4. Able to complete at least 80% of the electronic diary during the treatment period.

5. 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 criteria

1. Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during study participation.
2. Presence of a condition or abnormality that the investigator believes would affect the safety of the patient or the quality of the data.
3. History of ear surgery (excluding ear tube surgery).
4. 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.
5. More than two preventive migraine medications have failed.
6. Previous or current treatment with CGRP class drugs.
7. 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).
8. History of mania, psychosis, or suicidal ideation.
9. 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.
10. History of drug or alcohol abuse within the 12 months prior to screening, based on the participant's medical records or self-report.
11. 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 design

2,000 participants in 4 patient groups

A1

Description:

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.

Treatment:

Drug: CGRP R Inhibitor; CGRP Inhibitor

A2

Description:

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.).

Treatment:

Drug: none-CGRP

B1

Description:

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.

Treatment:

Drug: CGRP R Inhibitor; CGRP Inhibitor

B2

Description:

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.).

Treatment:

Drug: none-CGRP