Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.

Official Title
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Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rimegepant
* Drug: Various
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (All Pregnancies): All pregnant women aged 16 to 49 years, inclusive, at the estimated LMP within the study observation period are eligible to enter in the study. Exclusion Criteria (All Pregnancies): Has insufficient information to estimate LMP Has at least 1 pharmacy dispensing for ditans (i.e., lasmiditan) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period Has at least 1 pharmacy dispensing for a CGRP receptor antagonist other than rimegepant (i.e., ubrogepant, atogepant, and zavegepant) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period Has at least 1 pharmacy dispensing for CGRP monoclonal antibodies (i.e., erenumab, fremanezumab, eptinezumab, and galcanezumab) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period Additional Eligibility Criteria (Rimegepant-Exposed Group): Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period Have a recorded outcome of pregnancy within the study period Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days Additional Inclusion Criteria (Primary Comparator Group): Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period Have at least 1 pharmacy dispensing for a medication indicated for the treatment of migraine within the 30-day time window before the estimated LMP and ending with whichever is first: end of pregnancy or end of the study period. Have a recorded outcome of pregnancy within the study period Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days Additional Exclusion Criteria (Primary Comparator Group): • Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period Additional Inclusion Criteria (Secondary Comparator Group): Have no migraine diagnosis any time before the estimated LMP through whichever is first: end of pregnancy or end of the study period Have a recorded outcome of pregnancy within the study period Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days Additional Exclusion Criteria (Secondary Comparator Group): • Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 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 |
| --- | --- |
| Pregnancies in women with migraine and exposure to rimegepant<br> | Drug: Rimegepant<br>* Rimegepant 75mg<br>|
| Pregnancies in women with migraine exposed to other medications<br>Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine | Drug: Various<br>* Various<br>|
| Pregnancies in women without migraine<br> | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births |  | Annually beginning April 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elective terminations |  | Annually beginning April 2022 | 
| Preterm births |  | Annually beginning April 2022 | 
| Pre-eclampsia/eclampsia |  | 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 Disorder, Migraine Prevention, Prevention of Migraine, Pregnant, Pregnancy, Infant