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

NCT06221267 | Recruiting

• 1 other identifier: SYSKY-2023-1172-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (4)

• Treatment Satisfaction Questionnaire for Medication (TSQM)

  Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant

  4 weeks

• 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

• 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

• 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

Interventions

Rimegepant DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 24, 2024
• Study Start: January 26, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)