Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy (NCT05198245) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
United States1 participantsStarted 2021-12-15
Plain-language 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.
Who can participate
Age range16 Years – 49 Years
SexFEMALE
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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 medic…
What they're measuring
1
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births