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Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

NCT05198245

Active Not RecruitingN/A

Sponsor: Pfizer

Conditions: Migraine

Interventions: Rimegepant, Various, No intervention

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 16 Years to 49 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

New York, New York, United States