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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CGRP R Inhibitor; CGRP Inhibitor
DrugParticipants 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-CGRP
DrugParticipants 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.
Treatment groups
2,000 Participants
are divided into 4 treatment groupsGroup A: A11 intervention
Group B: A21 intervention
Group C: B11 intervention
Group D: B21 intervention
Trial outcomes
Primary outcomes
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
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 medication2
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 treatmentSecondary 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
Time frame
Within 48 hours post-dose of medication for group A1 and A2, 12-weeks after treatment for group B1 and B2Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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