Migraine
Conditions
Brief summary
This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.
Interventions
DRUGRimegepant
No intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with headaches that meet the diagnostic criteria for migraines according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura. * Patients prescribed rimegepant by the attending physician for the treatment of migraines. * Signed informed consent form. * Age greater than 18 years. * Not concurrently participating in other interventional clinical studies.
Exclusion criteria
* Patients diagnosed with secondary headaches. * Patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up. * Pregnant or lactating female patients. * Patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up. * Patients with a known history of hypersensitivity reactions to rimegepant or its components. * Evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication (TSQM) | 4 weeks | Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant |
| European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) | 4 weeks | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) score for the impact of rimegepant on the quality of life of migraine patients |
| Headache Impact Test-6 (HIT-6) | 4 weeks | Headache Impact Test-6 (HIT-6) score for the impact of rimegepant on the functioning of migraine patients |
| Work Productivity and Activity Impairment-General Health (WPAI-GH) | 4 weeks | Work Productivity and Activity Impairment-General Health (WPAI-GH) score for the impact of rimegepant on the productivity and work efficiency of migraine patients |
Countries
China
Outcome results
None listed