Migraine drug rimegepant's pregnancy safety under review
NCT ID NCT05198245
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This study looks at whether the migraine medication rimegepant is safe to take during pregnancy. Researchers will compare pregnancy outcomes in women who took rimegepant to those who did not. The study includes women aged 16 to 49 with migraine. However, only one person has been enrolled so far, so results are very limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rimegepant
- What this could lead to
- If successful, this study could provide important safety information about using rimegepant during pregnancy, helping doctors and patients make informed decisions.
- What could go wrong
- This is a small, retrospective study with only one enrolled participant, so results may not be reliable or generalizable to all pregnant women with migraine.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 1 person
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2021
- Expected to finish
-
Apr 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population will consist of pregnant women (any age) as well as the infants (male and female) born to enrolled participants through age 1 year
- Ages
-
16 to 49 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pfizer
New York, New York, 10001, United States
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