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Clinical study of precise treatment of acute migraine with Rimegepant guided by serum CGRP level: a prospective, multicenter and observational cohort study

Clinical study of precise treatment of acute migraine with Rimegepant guided by serum CGRP level: a prospective, multicenter and observational cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107844
Enrollment
Unknown
Registered
2025-08-19
Start date
2024-05-23
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute phase of migraine attack

Interventions

CGRP high expression group:None
CGRP low expression group:None

Sponsors

Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactZhang Qingxiu

Drum Tower Hospital

zhangqingxiu@163.com+86 15052009658

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026