- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06221267
A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
May 19, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
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
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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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
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Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant
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4 weeks
|
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European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame: 4 weeks
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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
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4 weeks
|
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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
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2023-1172-01
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.
Clinical Trials on Migraine
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Hospital Universitari Vall d'Hebron Research InstituteRecruitingMigraine | Migraine Headache | Migraine Without Aura | Migraine with Aura | Chronic Migraine, Headache | Episodic Migraine | Chronic Migraine Headache | Headache (Migraine) | Episodic Migraine HeadacheSpain
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Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
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Brigham and Women's HospitalNot yet recruitingMigraine Disorders | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
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Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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University of AlbertaCanadian Institutes of Health Research (CIHR)CompletedMigraine Without Aura | Migraine With Aura | Probable MigraineCanada
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Ariston Pharmaceuticals, Inc.UnknownMigraine | Migraine Disorders | Migraine Headache | Migraine Without Aura | Migraine With AuraFinland, Netherlands, United Kingdom
Clinical Trials on Rimegepant
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University of FlorenceUniversity of Roma La Sapienza; Fondazione I.R.C.C.S. Istituto Neurologico... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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PfizerPPD, Part of Thermo Fisher ScientificRecruiting
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PfizerNot yet recruitingAcute Treatment of MigraineUnited States
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Icahn School of Medicine at Mount SinaiPfizerTerminated
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Chinese PLA General HospitalActive, not recruiting
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PfizerRecruitingAcute Treatment of MigraineUnited States, Spain, Poland
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PfizerCompletedMigraine | Photophobia | Episodic Migraine | PhonophobiaUnited States
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PfizerCompletedMigraineItaly, Spain, Belgium, United States, Finland, Poland, Canada, Austria, United Kingdom, Sweden, Australia, Denmark, Germany, Mexico
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PfizerNot yet recruiting
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PfizerRecruitingPediatric MigraineUnited States, Spain, Canada, China, Poland, United Kingdom, Japan, Sweden, Mexico