Acute phase of migraine attack
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age range: 18-65 years old, male or female not limited; 2.Complies with the third edition of the International Classification of Headache Disorders (ICHD-3) for migraine diagnosis; 3.Within the first 3 months of enrollment: moderate or severe migraine attacks occur 2-8 times per month, and the number of headache days per month is less than 15 days; 4.Participants who reported the use of migraine-preventive medication were required to confirm that they had been taking a stable dose for at least 3 months; 5.Capable of independently completing and recording headache diaries in a standardized manner; 6.Sign informed consent form; 7.Not simultaneously involved in other interventional clinical studies; 8.The attending physician prescribed rimegepant for the treatment of migraine patients;
Exclusion criteria
Exclusion criteria: 1.There is current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease; 2.Severe liver and kidney dysfunction; 3.Evidence of alcohol or drug abuse in the past 12 months; 4.Have a history of severe drug or food allergies, or a severe allergic constitution; 5.Individuals who are unable to complete blood tests during or within one day after a migraine attack; 6.Pregnant women or men/women who plan to conceive within 6 months; 7.Lactating women; 8.Having mental symptoms or cognitive impairment that prevent informed completion; 9.Known allergy to rimegepant; Simultaneously using drugs with drug interactions with rimegepant; 10.Other situations that doctors consider necessary to exclude;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients without the most bothersome symptoms within 2 hours after treatment;The proportion of painless patients 2 hours after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of pain relief at 2 h after administration compared with pain at baseline episodes;Proportion of pain-free patients at 15, 30, 45, 60, and 90 minutes after dose;Proportion without the most bothersome symptom at 15, 30, 45, 60, and 90 minutes after dose;Proportion of patients with any level of dysfunction at baseline episode who returned to normal function 2 hours after dose;Proportion of rescue medications used 24 hours after dose;Proportion of patients who remained pain-free from 2-24 h after administration;Proportion of patients who remained pain-free from 2-48 hours after administration;Proportion of pain recurrences 2-48 hours after administration;Incidence of gastrointestinal symptoms such as nausea;Incidence of urinary tract infection; | — |
Countries
China
Contacts
Drum Tower Hospital