Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Last updated: January 6, 2026
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Pain

Oral Facial Pain

Treatment

Various

Rimegepant

No intervention

Clinical Study ID

NCT05198245
BHV3000-403
C4951006
  • Ages 16-49
  • Female

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 Criteria

Inclusion

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

Study Design

Total Participants: 1
Treatment Group(s): 3
Primary Treatment: Various
Phase:
Study Start date:
December 15, 2021
Estimated Completion Date:
April 17, 2028

Connect with a study center

  • Pfizer

    New York, New York 10001
    United States

    Site Not Available

  • Pfizer

    New York 5128581, New York 5128638 10001
    United States

    Site Not Available

  • Research Triangle Institute d/b/a RTI Health Solutions

    Research Triangle Park, North Carolina 27709
    United States

    Site Not Available

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