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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221267
• Other study ID #: SYSKY-2023-1172-01
• Status: Recruiting
• Start date: January 26, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
No intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction Questionnaire for Medication (TSQM)	Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant	4 weeks
Primary	European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)	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	4 weeks
Primary	Headache Impact Test-6 (HIT-6)	Headache Impact Test-6 (HIT-6) score for the impact of rimegepant on the functioning of migraine patients	4 weeks
Primary	Work Productivity and Activity Impairment-General Health (WPAI-GH)	Work Productivity and Activity Impairment-General Health (WPAI-GH) score for the impact of rimegepant on the productivity and work efficiency of migraine patients	4 weeks