NCT06728345Not yet recruiting
The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Participants already taking Rimegepant (75mg QOD) as their regular preventive treatment of migraine for 12 weeks will be evaluated as the followings : 1. To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12 2. To evaluate the number of participants that have least a 50% reduction from baseline in the mean number of migraine days per month during weeks 1-12
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Migraine
- NCT number
- NCT06728345
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Dec 2024 to the primary completion date, 30 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subjects who are allergic to rimegepant or any of its excipients.
- Patients with severe liver damage or end-stage renal disease.
- Any condition deemed by the investigator that might affect the patient's participation in the study.
Other
- Patients diagnosed with secondary headaches.
- Women who are pregnant or breastfeeding.
- 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.
- Subjects lacking the equipment to complete questionnaires on a digital platform.
Who the study is looking for
- Female participants aged ≥ 18 years-old
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.