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

Официальное название

The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Rimegepant
  Female migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks

Первичные конечные точки

• Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12) [Срок оценки: The treatment period is 12 weeks]
• Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12) [Срок оценки: The treatment period is 12 weeks]

Вторичные конечные точки (6)

• Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12) [Срок оценки: The treatment period is 12 weeks]
• Mean change from baseline in the Migraine Disability Assessment (MIDAS) [Срок оценки: Baseline, Week 12]
• Mean change from baseline in the migraine disability (HIT-6) [Срок оценки: Baseline , Week 4,8,12]
• Mean change from baseline in the Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline , Week 4,8,12]
• Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7) [Срок оценки: Baseline , Week 4,8,12]
• Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline , Week 4,8,12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Subjects who are allergic to rimegepant or any of its excipients.
• Patients with severe liver damage or end-stage renal disease.
• 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.
• Any condition deemed by the investigator that might affect the patient's participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06728345 · No.2024-454

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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