Chinese Real-world Study of Treatment of Vestibular Migraine

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

Male or female, aged between 18 and 75 years.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CGRP R Inhibitor; CGRP Inhibitor
  • none-CGRP

Treatment groups

2,000 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

First People's Hospital of Hangzhou

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

The People's Hospital of Quzhou

Collaborator

The First People Hospital of Hangzhou Lin An District

Collaborator

Shaoxing People's Hospital

Collaborator

Jiaxing Hospital of T.C.M

Collaborator

Hangzhou Hospital of Traditional Chinese Medicine

Collaborator

Affiliated Wenling Hospital of Wenzhou Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

The First People's Hospital of Huzhou

Collaborator

Xin Hua Hospital of Zhejiang Province

Collaborator

The Affiliated Hospital of Hangzhou Normal University

Collaborator

Huzhou Central Hospital

Collaborator

Chinese Medical University

Collaborator

Tiantai County People's Hospital

Collaborator

Zhejiang University

Collaborator