Current partner codePEPTIDESDE
NCT07203248·Not applicable·OBSERVATIONAL

Chinese Real-world Study of Treatment of Vestibular Migraine

Status

Not yet recruiting

Phase

Not applicable

Enrollment

2,000

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

CGRP R Inhibitor; CGRP Inhibitor

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.

DRUG

none-CGRP

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.

Timeline

From registration to results.

  1. First posted

    Oct 2, 2025

  2. Study start

    Dec 2025

  3. Primary completion

    Dec 2027

  4. Study completion

    Dec 2028

  5. Results posted

    Not reported

  6. Registry updated

    Oct 2, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · within 48 hours post-dose of CGRP medication

Vestibular symptom severity post-dose will be measured on Visual Analogue Scale (VAS) (0=No vestibular symptom, 10=worst vestibular symptom).

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

Time frame · 12 weeks after treatment

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.

Secondary outcomes

The percentage of patients satisfied with medication to evaluate the effectiveness of different treatment in the treatment of VM

Time frame · Within 48 hours post-dose of medication for group A1 and A2, 12-weeks after treatment for group B1 and B2

Satisfaction with medication will be measured via 7-point SM scale

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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