Clinical trial NCT05709106: A Prospective Real World Study of Rimegepant in the Treatment of Migraine
Official title: A Prospective Real World Study of Rimegepant in the Treatment of Migraine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Lead sponsor: Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

  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 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.

Primary outcomes:
measure: Change From Baseline on the percentage of participants that are pain relief at 2 hours post-dose during the migraine attack
timeFrame: Difference between baseline and 2 hours post-dose of Rimegepant
Secondary outcomes:
measure: 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
timeFrame: Difference between baseline and 0.5, 1, 24 and 48 hours post-dose of Rimegepant
measure: 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
timeFrame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
measure: 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
timeFrame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
measure: 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
timeFrame: Difference between baseline and 0.5, 1, 2, 24 and 48 hours post-dose of Rimegepant
measure: Change From Baseline in the Mean Number of Migraine Days Per Month Over the 12 months follow-up period.
timeFrame: From baseline to 12 months follow-up period
measure: 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
timeFrame: From baseline and month 3,6,12 in the 12 months follow-up
Other outcomes:
Locations:
city: Boao
country: China
facility: Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine
state: Hainan
Study officials:
affiliation: Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
name: Jun Liu
role: PRINCIPAL_INVESTIGATOR
References: