Status:
ACTIVE_NOT_RECRUITING
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Lead Sponsor:
Pfizer
Collaborating Sponsors:
RTI Health Solutions
Optum, Inc.
Conditions:
Migraine
Eligibility:
FEMALE
16-49 years
Brief 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
Exclusion
Key Trial Info
Start Date :
December 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 17 2028
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05198245
Start Date
December 15 2021
End Date
April 17 2028
Last Update
January 8 2026
Active Locations (1)
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1
Pfizer
New York, New York, United States, 10001