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CompletedNCT05709106Updated Feb 5, 2026

A Prospective Real World Study of Rimegepant in the Treatment of Migraine

An observational study in Migraine, sponsored by Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
173
Ages
18 Years and older
Sex
All
01

Study 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 of Rimegepant in the long-term treatment of migraine.

    1. Participants will be asked to take Rimegepant when they need to treat or prevent a migraine attack.
    2. 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
    3. 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.
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Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 173 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

This is the only study on the registry with Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
173 participants (actual)
Patient registry
No

Groups and cohorts

  • Rimegepant treatment group

    this group would use Rimegepant 75mg ODT, use it when needed for 1year

    Drug: Rimegepant 75 MG

Interventions

  • DrugRimegepant 75 MG

    Migraine patients would take Rimegepant 75 MG to treat or prevent a migraine attack and patients would be followed up for 1 year

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Difference between baseline and 2 hours post-dose of Rimegepant

Secondary outcomes

  1. 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.

    Time frame: Difference between baseline and 0.5, 1, 24 and 48 hours post-dose of Rimegepant

  2. 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

    Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant

  3. 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).

    Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant

  4. 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)

    Time frame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant

  5. 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.

    Time frame: From baseline to 12 months follow-up period

  6. 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.

    Time frame: From baseline and month 3,6,12 in the 12 months follow-up

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Study locations

1 site
  • Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine
    Boao, Hainan 571434, China
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05709106
Lead sponsor
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Responsible party
Sponsor
First posted
Feb 1, 2023
Start date
Jan 11, 2023
Primary completion
Oct 6, 2024
Completion
Apr 9, 2025
Last update
Feb 5, 2026

Study contacts

Jun Liu
principal investigator · Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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