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Active, not recruiting Observational

Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

NCT05198245 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Observational
Started
2021-12-15
Last updated
2026-10-29

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

Rimegepant →VariousNo intervention

Rimegepant: Rimegepant 75mg

Various: Various

No intervention: No intervention

Study 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.

Eligibility

Sex
FEMALE
Min age
16 Years
Max age
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 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

Primary outcome measure(s)

  • Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births — Annually beginning April 2022

Trial sites (1)

FacilityCityRegionStatus
Pfizer New York New York
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05198245 on ClinicalTrials.gov ↗ ← All trials in the USA