NCT05198245Active, not recruiting
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
RETROSPECTIVE COHORT STUDY OF PREGNANCY OUTCOMES IN WOMEN EXPOSED TO RIMEGEPANT DURING PREGNANCY
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1 (estimated)
- First submitted
- 15 Dec 2021
- Start date
- 15 Dec 2021
- Primary completion date
- 17 Apr 2028
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT05198245
What you commit to
- Study type: Observational
- Planned participants: 1
- From 15 Dec 2021 to the primary completion date, 17 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other
- 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
- 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 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
Who the study is looking for
- 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.
Age in the registry: 16 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.