Clinical trial NCT06728345: The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
Official title: The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine
Migraine Prophylaxis
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients diagnosed with migraine (with or without aura) who take rimegepant rimegepant 75 mg orally disintegrating tablet every other day for 12 weeks

Brief summary: 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

Detailed description: 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.

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.

Primary outcomes:
measure: Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12)
timeFrame: The treatment period is 12 weeks
measure: Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12)
timeFrame: The treatment period is 12 weeks
Secondary outcomes:
measure: Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12)
timeFrame: The treatment period is 12 weeks
measure: Mean change from baseline in the Migraine Disability Assessment (MIDAS)
timeFrame: Baseline, Week 12
measure: Mean change from baseline in the migraine disability (HIT-6)
timeFrame: Baseline , Week 4,8,12
measure: Mean change from baseline in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline , Week 4,8,12
measure: Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7)
timeFrame: Baseline , Week 4,8,12
measure: Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline , Week 4,8,12
Other outcomes:
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