Migraine
Conditions
Keywords
Migraine, Migraine Disorder, Migraine Prevention, Prevention of Migraine, Pregnant, Pregnancy, Infant
Brief summary
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.
Interventions
Sponsors
Pfizer
RTI Health Solutions
Optum, Inc.
Carelon Research, Inc
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births | Annually beginning April 2022 |
Secondary
| Measure | Time frame |
|---|---|
| Elective terminations | Annually beginning April 2022 |
| Preterm births | Annually beginning April 2022 |
| Pre-eclampsia/eclampsia | Annually beginning April 2022 |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed