Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Launched by PFIZER · Jan 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called rimegepant on pregnancy outcomes in women who have migraines. Researchers want to find out if using rimegepant during pregnancy affects the health of the mother and baby compared to women who did not use this medication. The trial is currently looking for pregnant women aged 16 to 49 who are either using rimegepant or have been treated for migraines without it.

To participate, women need to have a confirmed pregnancy and a history of migraines. They will be grouped based on whether they used rimegepant or another migraine treatment, or if they had no migraine history at all. Participants will be monitored throughout their pregnancy and shortly after, and they can expect to provide information about their health and pregnancy outcomes during this time. This study aims to help ensure the safety of migraine treatments for pregnant women and their babies.

Gender

FEMALE

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