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

NCT05709106 | Completed FDA Drug

• 1 other identifier: ky2022005
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Outcome Measures

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.

  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

  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

  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

  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

  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.

  From baseline to 12 months follow-up period

Study Arms (1)

Rimegepant treatment group

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

Drug: Rimegepant 75 MG

Interventions

Rimegepant 75 MG DRUG

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

Rimegepant treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine: lead

Study Sites (1)

Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine

Boao, Hainan, 571434, China

Location

Related Publications (1)

• 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.

  PMID: 39333875 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jun Liu

  Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 1, 2023
• Study Start: January 11, 2023
• Primary Completion: October 6, 2024
• Study Completion: April 9, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

CN (1)