Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
NCT ID: NCT05198245
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1 participants
OBSERVATIONAL
2021-12-15
2028-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pregnancies in women with migraine and exposure to rimegepant
Rimegepant
Rimegepant 75mg
Pregnancies in women with migraine exposed to other medications
Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine
Various
Various
Pregnancies in women without migraine
No intervention
No intervention
Interventions
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Rimegepant
Rimegepant 75mg
Various
Various
No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
• 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 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
16 Years
49 Years
FEMALE
No
Sponsors
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RTI Health Solutions
OTHER
Optum, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
New York, New York, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951006
Identifier Type: OTHER
Identifier Source: secondary_id
BHV3000-403
Identifier Type: -
Identifier Source: org_study_id
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