MigraineNCT05709106
A Prospective Real World Study of Rimegepant in the Treatment of Migraine
An observational study of Migraine, run by Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to test the effectiveness and safety of Rimegepant in the treatment of migraine patients in real world. The main questions it aims to answer are: [question 1] the effectiveness and safety of Rimegepant in the acute treatment of migraine [question 2] the effectiveness and safety… 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 75 MG
- How many people
- 173 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 9 Apr 2025
- 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: This study will be conducted in the headache clinic of Ruijin-hainan hospital. Participants meeting the inclusion and exclusion criteria will be enrolled continuously.
Who may be able to join
- Subjects diagnosed as migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, beta version
- Rimegepant is prescribed by the physician for the treatment of patients with migraine.
- Patients signed written informed consent.
- Male and Female subjects ≥ 18 years and older
- Patients is not participated in other concurrent interventional clinical studies.
Who cannot join
- The patients with severe visual, hearing, language, intelligence, memory, and consciousness disorders, are unable to cooperate with the completion of the questionnaire and follow-up.
- Pregnant patients
- Lactating female patients
- Patients who are highly dependent on medical care.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine
Boao, Hainan, 571434
About this study
The goal of this observational study is to test the effectiveness and safety of Rimegepant in the treatment of migraine patients in real world.
The main questions it aims to answer are:
Read more
- [question 1] the effectiveness and safety of Rimegepant in the acute treatment of migraine
- [question 2] the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
- Participants will be asked to take Rimegepant when they need to treat or prevent a migraine attack.
- Participants will be asked to record the efficacy data at 0.5, 1, 2, 24, 48h post dose and report any AE to evaluate the effectiveness and safety of Rimegepant in the acute treatment of migraine
- Participants will be asked to track monthly migraine days and the use of Rimegepant, finish 2 PROs during the follow-ups, report any AE to evaluate the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
- Conditions
- Migraine
- Being tested
- Rimegepant 75 MG
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 MGDrug
Migraine patients would take Rimegepant 75 MG to treat or prevent a migraine attack and patients would be followed up for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant treatment group | this group would use Rimegepant 75mg ODT, use it when needed for 1year Receives: Drug: Rimegepant 75 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack
Pain Relief at 2 hours post-dose will be assessed using the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose.
Measured: Difference between baseline and 2 hours post-dose of Rimegepant
Secondary outcomes (6)
Change From Baseline on percentage of participants that are pain relief at 0.5,1,24 and 48 hours post-dose during the migraine attack
Pain Relief at 0.5,1,24 and 48 hours post-dose will be assessed using the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at 0.5,1,24 and 48 hours post-dose.
Measured: Difference between baseline and 0.5, 1, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of subjects able to function normally, at 0.5, 1, 2, 24 and 48 hours post-dose, will be accessed by the Functional Disability scale
The ability to function normally will be measured using the number of subjects that self-report as "normal" on the Functional Disability scale
Measured: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of participants that are pain freedom at 0.5,1, 2, 24 and 48 hours post-dose during the migraine attack
Pain freedom will be assessed using the number of evaluable subjects that report no pain at 0.5,1,2,24 and 48 hours post-dose. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Measured: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of participants that are freedom from Most Bothersome Symptoms MBS (nausea, phonophobia or photophobia) at 0.5,1,2,24 and 48 hours post-dose during the migraine attack
Freedom from Most Bothersome Symptom will be measured using the number of subjects that report the absence of their MBS (nausea, phonophobia or photophobia) and will measured as (0=absent, 1=present)
Measured: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline in the Mean Number of Migraine Days Per Month Over the 12 months follow-up period.
A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. (A month is defined as 4 weeks for the purpose of this protocol).The change from baseline was calculated as the number of monthly migraine days during the every 4 weeks of the 12 months follow-up period minus number of monthly migraine days of baseline.Baseline is defined as the number of migraine days during the last 28 days prior to the recruiting date.
Measured: From baseline to 12 months follow-up period
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) total score and Headache Impact Test (HIT-6) total score at month 3,6,12 in the 12 months follow-up
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks.The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations.
Measured: From baseline and month 3,6,12 in the 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start11 Jan 2023
- Primary completion6 Oct 2024
- Study completion9 Apr 2025
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Liu, Principal investigator, Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709106
- Sponsor's protocol ID
- ky2022005
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang Z, Wang X, Niu M, Wei Q, Zhong H, Li X, Yuan W, Xu W, Zhu S, Yu S, Liu J, Yan J, Kang W, Huang P. First real-world study on the effectiveness and tolerability of rimegepant for acute migraine therapy in Chinese patients. J Headache Pain. 2024 Sep 27;25(1):160. doi: 10.1186/s10194-024-01873-5.
PubMed 39333875
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Real World Study of Rimegepant in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT05709106
- Acronym / sponsor ID
- ky2022005
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of MedicineUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 1 Feb 2023 (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.
The goal of this observational study is to test the effectiveness and safety of Rimegepant in the treatment of migraine patients in real world.
The main questions it aims to answer are:
- [question 1] the effectiveness and safety of Rimegepant in the acute treatment of migraine
- [question 2] the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
- Participants will be asked to take Rimegepant when they need to treat or prevent a migraine attack.
- Participants will be asked to record the efficacy data at 0.5, 1, 2, 24, 48h post dose and report any AE to evaluate the effectiveness and safety of Rimegepant in the acute treatment of migraine
- Participants will be asked to track monthly migraine days and the use of Rimegepant, finish 2 PROs during the follow-ups, report any AE to evaluate the effectiveness and safety of Rimegepant in the long-term treatment of migraine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rimegepant treatment group | – | Drug: Rimegepant 75 MGthis group would use Rimegepant 75mg ODT, use it when needed for 1year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in the headache clinic of Ruijin-hainan hospital. Participants meeting the inclusion and exclusion criteria will be enrolled continuously.
Key inclusion criteria (5 listed)
- Subjects diagnosed as migraines (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, beta version
- Rimegepant is prescribed by the physician for the treatment of patients with migraine.
- Patients signed written informed consent.
- Male and Female subjects ≥ 18 years and older
- Patients is not participated in other concurrent interventional clinical studies.
Key exclusion criteria (4 listed)
- The patients with severe visual, hearing, language, intelligence, memory, and consciousness disorders, are unable to cooperate with the completion of the questionnaire and follow-up.
- Pregnant patients
- Lactating female patients
- Patients who are highly dependent on medical care.
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 |
|---|---|---|
| Rimegepant 75 MGMigraine patients would take Rimegepant 75 MG to treat or prevent a migraine attack and patients would be followed up for 1 year | Drug | Rimegepant treatment group |
Primary outcome
Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack
Time frame: Difference between baseline and 2 hours post-dose of Rimegepant
Pain Relief at 2 hours post-dose will be assessed using the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose.
6 secondary outcomes
Change From Baseline on percentage of participants that are pain relief at 0.5,1,24 and 48 hours post-dose during the migraine attack
Time frame: Difference between baseline and 0.5, 1, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of subjects able to function normally, at 0.5, 1, 2, 24 and 48 hours post-dose, will be accessed by the Functional Disability scale
Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of participants that are pain freedom at 0.5,1, 2, 24 and 48 hours post-dose during the migraine attack
Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline on the percentage of participants that are freedom from Most Bothersome Symptoms MBS (nausea, phonophobia or photophobia) at 0.5,1,2,24 and 48 hours post-dose during the migraine attack
Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
Change From Baseline in the Mean Number of Migraine Days Per Month Over the 12 months follow-up period.
Time frame: From baseline to 12 months follow-up period
Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 (MSQ) total score and Headache Impact Test (HIT-6) total score at month 3,6,12 in the 12 months follow-up
Time frame: From baseline and month 3,6,12 in the 12 months follow-up
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 5 Feb 2026.
- Derived from this study: PubMed 39333875Yang Z, Wang X, Niu M, Wei Q, Zhong H, Li X, Yuan W, Xu W, Zhu S, Yu S, Liu J, Yan J, Kang W, Huang P. First real-world study on the effectiveness and tolerability of rimegepant for acute migraine therapy in Chinese patients. J Headache Pain. 2024 Sep 27;25(1):160. doi: 10.1186/s10194-024-01873-5.
- Individual participant dataSharing planned: Undecided
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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.
Jun Liu principal investigator
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
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 Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine 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 4 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 5 Feb 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?
Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack (time frame: Difference between baseline and 2 hours post-dose of Rimegepant). 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 NCT05709106, 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 5 Feb 2026.