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

Last updated: July 4, 2024
Sponsor: Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain (Pediatric)

Oral Facial Pain

Treatment

Rimegepant 75 MG

Clinical Study ID

NCT05709106
ky2022005
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects diagnosed as migraines (with or without aura) consistent with a diagnosisaccording to the International Classification of Headache Disorders, 3rd Edition,beta version

  • Rimegepant is prescribed by the physician for the treatment of patients withmigraine.

  • Patients signed written informed consent.

  • Male and Female subjects ≥ 18 years and older

  • Patients is not participated in other concurrent interventional clinical studies.

Exclusion

Exclusion Criteria:

  • The patients with severe visual, hearing, language, intelligence, memory, andconsciousness disorders, are unable to cooperate with the completion of thequestionnaire and follow-up.

  • Pregnant patients

  • Lactating female patients

  • Patients who are highly dependent on medical care.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Rimegepant 75 MG
Phase:
Study Start date:
January 11, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine

    Boao, Hainan 571434
    China

    Active - Recruiting

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