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The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients
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
This single arm, prospective, multi-center, observational registry study aim to evaluate effectiveness of rimegepant as preventive migraine treatment in the real-world setting. About 300 adult migraine participants will be enrolled continuously at 6 sites with a headache clinic or headache center in China. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline data including demographic information, socio-economic information, physical examination, medical history, migraine history and past use of headache medications will be collected at the baseline visit. The treatment period will last for 12 weeks during which patients will take rimegepant 75 mg orally disintegrating tablet every other day. The efficacy of rimegepant measured by the reduction in the number of migraine days per month. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Data will be collected at baseline and every month. At study visits, participants will complete the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8 and 12; and participants will complete the Migraine Disability Assessment (MIDAS) at weeks 12.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
Start Date
December 1, 2024
Primary Completion Date
June 30, 2026
Completion Date
December 31, 2027
Last Updated
December 11, 2024
300
ESTIMATED participants
Rimegepant
DRUG
Lead Sponsor
The First Affiliated Hospital of Soochow University
NCT07018713
NCT06641466
NCT04715685
Data Source & Attribution
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