A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Recruiting

• Conditions: Migraine

• Registration Number: NCT06221267
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-24
• Study Start: 2024-01-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China