The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects and safety of a medication called Rimegepant for treating migraines in women, particularly those who are young or middle-aged. The goal is to see how well Rimegepant helps reduce the number of migraine days women experience each month. Women who have been using Rimegepant regularly for at least 12 weeks will be observed to find out how their migraine frequency changes during the study period.

To participate in this study, women must be at least 18 years old and have been diagnosed with migraines, experiencing four or more migraine days per month. They should also have been experiencing migraines for over a year and be currently using Rimegepant as prescribed by their doctor. Participants will be asked to share their experiences and complete questionnaires, but they should not be involved in other conflicting studies and must not have certain health conditions, like severe heart disease or liver problems. This study is not yet recruiting participants, so there will be more information available as it progresses.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female participants aged ≥ 18 years-old
• • 2. Primary diagnosis of migraine according to ICHD-3 3.4 or more migraine days during Observation Period and Screening Visit
• • 4.Migraine attacks present for more than 1 year 5.Rimegepant is prescribed for the preventive treatment of migraine by physician 6.Written informed consent must be obtained before participant is enrolled 7.Not concurrently participating in other interventional clinical studies.
• Exclusion Criteria:
• • 1. Patients diagnosed with secondary headaches.
• • 2. Women who are pregnant or breastfeeding.
• • 3. Subjects with severe impairments in language, vision, memory, or cognitive function that affect communication and understanding, or those who are unable to complete questionnaires or follow-ups.
• • 4. Subjects lacking the equipment to complete questionnaires on a digital platform.
• • 5. Subjects who are allergic to rimegepant or any of its excipients.
• • 6. Patients with severe liver damage or end-stage renal disease.
• • 7. Patients with a medical history indicating the presence of uncontrolled or unstable cardiovascular disease (such as ischemic heart disease, coronary artery spasm, or cerebral ischemia), or those who have had a myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within 6 months prior to the screening visit.
• • 8. Any condition deemed by the investigator that might affect the patient's participation in the study.