Clinical Trials in the USA / NCT05198245
Active, not recruiting
Observational
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
NCT05198245 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Migraine
Investigational drug(s) / intervention(s)
Rimegepant: Rimegepant 75mg
Various: Various
No intervention: No intervention
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
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
Primary outcome measure(s)
- Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births — Annually beginning April 2022
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Pfizer | New York | New York |
On this site
📄 Nurtec ODT (rimegepant) drug profile →More Pfizer trials in the USA
Other trials for the same condition
Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
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Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
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A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
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Nerivio Efficacy Under High-Frequency Use
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05198245 on ClinicalTrials.gov ↗ ← All trials in the USA