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Research question and objectives Primary endpoint
• To evaluate the effectiveness of Rimegepant in the acute treatment of migraine as measured by most severe pain, onset of pain relief, satisfaction with pain relief, and satisfaction with return to normal function post-dose.
Secondary Objectives
Exploratory Objective
Study design This is a single arm, prospective, multi-center, observational registry study with participants receiving Rimegepant for the acute treatment of migraine in a real-world setting. Each participant will receive treatment and care according to standard clinical practice.
About 3,000 adult migraine participants will be enrolled continuously at 70 to 73 sites with a headache clinic or headache center in China in approximately 16 consecutive months or until reaching the target sample size.. The index date for a participant will be the date of enrollment. The maximum follow-up period per participant after enrollment is 12 months.
At the Baseline Visit, the demographics information, socioeconomic characteristics, and medical and migraine history will be collected from the enrolled participants. For the acute treatment effectiveness evaluation, data on Rimegepant treating single migraine attack including the timing of dosing, most severe pain, onset time of pain relief, onset time of associated symptoms relief, satisfaction with pain relief and satisfaction with function improvement are expected to be captured within 3 months after enrollment through a digital platform. If none of these data are captured within 3 months, the participant will be marked as failed in the study and will not be followed up further. For the long-term effectiveness evaluation, participants will use an eDiary to record headache and migraine occurrence, and use a digital platform to collect Rimegepant and other migraine-related medication usage days every month. At study visits, participants will complete the Migraine-Specific Quality-of-Life Questionnaire (MSQ) v2.1, Migraine Disability Assessment (MIDAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Patient Global Impression of Change (PGI-C) and the Satisfaction with Medication (SM) scale at months 3, 6 and 12 via electronic patient reported outcomes (ePROs). The previous four scales will be completed by participants at baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | patients take rimegepant to treat migraine attack as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| The average scores of the most severe pain post-dose measured by VAS scale to evaluate the effectiveness of Rimegepant in the acute treatment of migraine | Pain severity post-dose will be measured on Visual Analogue Scale (VAS) (0=No pain, 10=worst pain). | within 48 hours post-dose of rimegepant |
| The onset time of pain relief post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine | Onset of pain relief is defined as the earliest time point after dosing at which the participant feels that the medication has started working to relieve the pain. If the participant remains pain free both at and after dosing, the time should be recorded as 0 | within 48 hours post-dose of rimegepant |
| The percentage of patients satisfied with pain relief post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine | Satisfaction with pain relief will be measured via 7-point SM scale | within 48 hours post-dose of rimegepant |
| The percentage of patients satisfied with return to normal function post-dose to evaluate the effectiveness of Rimegepant in the acute treatment of migraine | Satisfaction with pain relief will be measured via 7-point SM scale | within 48 hours post-dose of rimegepant |
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Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria:
Participants meeting any of the following criteria will not be included in the study:
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The study will recruit male and female participants in China, 18 years of age or older with migraine (with or without aura), diagnosed according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)21. Participants must be prescribed with Rimegepant according to the clinical decision of the doctor and the willingness of the participants.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China | |||
| Peking University People's Hospital |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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| Beijing |
| Beijing Municipality |
| China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhenjiang | China |
| D009422 | Nervous System Diseases |