Evaluating pregnancy outcomes in women exposed to rimegepant
Official title: Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Run by Pfizer · NCT05198245 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see if using the migraine medication rimegepant during pregnancy affects the health of both the mother and baby compared to women who didn't use it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 49 Years |
| Sex | Women only |
| Enrollment | 1 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | erenumab, fremanezumab, eptinezumab, galcanezumab |
| Locations | 1 site (Research Triangle Park, North Carolina) |
| Trial ID | NCT05198245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 16 to 49 years who are experiencing migraines.
✕Probably not a fit
Patients who are not pregnant or those who have used other migraine treatments within the specified time frame may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the risks associated with pregnancy outcomes in women who have been exposed to rimegepant, a medication used for migraine treatment, during pregnancy. It will compare these outcomes with two groups of women who were not exposed to rimegepant. The study will include pregnant women aged 16 to 49 years and will gather data on various pregnancy and infant outcomes. The goal is to provide insights into the safety of rimegepant use during pregnancy.
Why it matters
Potential benefit: If successful, this study could provide valuable information regarding the safety of rimegepant for pregnant women suffering from migraines.
How similar studies have gone: While there have been studies on migraine treatments during pregnancy, the specific evaluation of rimegepant's effects is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Research Triangle Institute d/b/a RTI Health Solutions
Research Triangle Park, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Pfizer Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.