Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

Study Overview
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Brief Summary
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The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Official Title
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A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)

Conditions
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Migraine

Intervention / Treatment
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* Other: Rimegepant
* Other: Not taking Rimegepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception) Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy Exclusion Criteria: • Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with migraine exposed to Rimegepant<br>Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception) | Other: Rimegepant<br>* 75mg<br>|
| Pregnant women with migraine not exposed to Rimegepant<br>Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy | Other: Not taking Rimegepant<br>* No rimegepant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major congenital malformation (birth defect) | Healthcare provider report through the registry | Annually beginning April 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor congenital malformation | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Gestational hypertension | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Pre-eclampsia | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Eclampsia | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Gestational diabetes | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Spontaneous abortion | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Stillbirth | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Elective termination | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Preterm birth | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Small for gestational age | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Postnatal growth deficiency | Healthcare provider report through the registry | Annually beginning April 2022 | 
| Infant developmental delay | Healthcare provider report through the registry | Annually beginning April 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Migraine Headache, Pregnant, Pregnancy, Infant