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Migraine drug rimegepant's pregnancy safety under review

NCT ID NCT05198245

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • Pfizer

    New York, New York, 10001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.