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| Name | Class |
|---|---|
| First People's Hospital of Hangzhou | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| The People's Hospital of Quzhou |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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.). |
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| 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. |
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| 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.). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGRP R Inhibitor; CGRP Inhibitor | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 48 hours post-dose of medication for group A1 and A2, 12-weeks after treatment for group B1 and B2 |
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Inclusion Criteria:
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.
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.
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.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaiming Liu, MD, PhD | Contact | +8615068862055 | 2314411@zju.edu.cn |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077221 | Calcitonin Gene-Related Peptide Receptor Antagonists |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
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| OTHER |
| The First People Hospital of Hangzhou Lin An District | UNKNOWN |
| Shaoxing People's Hospital | OTHER |
| Jiaxing Hospital of T.C.M | UNKNOWN |
| Hangzhou Hospital of Traditional Chinese Medicine | OTHER |
| Affiliated Wenling Hospital of Wenzhou Medical University | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Zhongshan Hospital Of Traditional Chinese Medicine | OTHER |
| The First People's Hospital of Huzhou | OTHER |
| Xin Hua Hospital of Zhejiang Province | OTHER |
| The Affiliated Hospital of Hangzhou Normal University | OTHER |
| Huzhou Central Hospital | OTHER |
| Chinese Medical University | UNKNOWN |
| Tiantai County People's Hospital | OTHER |
| Zhejiang University | OTHER |
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| none-CGRP | Drug | 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. |
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| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009422 | Nervous System Diseases |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |