Clinical trial NCT06221267: A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
Official title: A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively enroll 120 migraine patients who meet the inclusion criteria and are receiving treatment with rimegepant in selected outpatient clinics in the Guangdong-Hong Kong-Macao Greater Bay Area

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 4 weeks
measure: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: 4 weeks
measure: Headache Impact Test-6 (HIT-6)
timeFrame: 4 weeks
measure: Work Productivity and Activity Impairment-General Health (WPAI-GH)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: