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

Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine

Status: Completed

Conditions: Migraine

Treatments: Drug: Rimegepant 75 MG

Study type: Observational

Funder types: Other

Identifiers

NCT05709106

ky2022005

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

173 participants in 1 patient group

Rimegepant treatment group

Description:

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

Treatment:

Drug: Rimegepant 75 MG