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

NCT ID: NCT05709106

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-11

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rimegepant treatment group

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

Rimegepant 75 MG

Intervention Type DRUG

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

Interventions

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Rimegepant 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

Intervention Type DRUG

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Liu

Role: PRINCIPAL_INVESTIGATOR

Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Locations

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Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine

Boao, Hainan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenyan Kang

Role: CONTACT

+86 13816512546

Facility Contacts

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Wenyan KANG

Role: primary

+86 13816512546

Jun Liu

Role: backup

References

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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.

Reference Type DERIVED
PMID: 39333875 (View on PubMed)

Other Identifiers

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ky2022005

Identifier Type: -

Identifier Source: org_study_id

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