MigraineNCT06221267
A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
An observational study of Migraine, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 30 Jun 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
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
- Being tested
- Rimegepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
No intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant
Measured: 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
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start26 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221267
- Sponsor's protocol ID
- SYSKY-2023-1172-01
- Status last verified
- May 2026
- First submitted
- 28 Dec 2023
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang J, Jiang J, Peng S, Jiang J, Liu Z, Cai J, Li J, Li Y, Chen Y, Li H, Rong X, He L, Ren L, Ji Y, Li S, Zhu Y, Xiao S, Tang Y, Xu Y. Patient-reported outcomes of rimegepant for acute and preventive treatment of migraine in China: a prospective, multicenter, real-world study. J Headache Pain. 2025 Nov 7;26(1):242. doi: 10.1186/s10194-025-02197-8.
PubMed 41204073
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area
- ClinicalTrials.gov ID
- NCT06221267
- Acronym / sponsor ID
- SYSKY-2023-1172-01
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantNo intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting. | Drug | – |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 41204073Wang J, Jiang J, Peng S, Jiang J, Liu Z, Cai J, Li J, Li Y, Chen Y, Li H, Rong X, He L, Ren L, Ji Y, Li S, Zhu Y, Xiao S, Tang Y, Xu Y. Patient-reported outcomes of rimegepant for acute and preventive treatment of migraine in China: a prospective, multicenter, real-world study. J Headache Pain. 2025 Nov 7;26(1):242. doi: 10.1186/s10194-025-02197-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction Questionnaire for Medication (TSQM) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.