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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: 4 weeks
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)
Time Frame: 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
4 weeks
Headache Impact Test-6 (HIT-6)
Time Frame: 4 weeks
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)
Time Frame: 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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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