MigraineNCT05198245
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
An observational study of Migraine, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant and Various
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RETROSPECTIVE COHORT STUDY OF PREGNANCY OUTCOMES IN WOMEN EXPOSED TO RIMEGEPANT DURING PREGNANCY
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.
- Conditions
- Migraine
- Being tested
- Rimegepant, Various, No intervention
- Keywords
- Migraine, Migraine Disorder, Migraine Prevention, Prevention of Migraine, Pregnant, Pregnancy, Infant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant 75mg
VariousDrug
Various
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies in women with migraine and exposure to rimegepant | Not described Receives: Drug: Rimegepant | |
| Pregnancies in women with migraine exposed to other medications | Pregnancies in women with migraine exposed to other medications indicated for the treatment of migraine Receives: Drug: Various | |
| Pregnancies in women without migraine | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births
Measured: Annually beginning April 2022
Secondary outcomes (3)
Elective terminations
Measured: Annually beginning April 2022
Preterm births
Measured: Annually beginning April 2022
Pre-eclampsia/eclampsia
Measured: Annually beginning April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start15 Dec 2021
- Primary completion17 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions, Optum, Inc., Carelon Research, Inc
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198245
- Sponsor's protocol ID
- BHV3000-403
- Other IDs
- C4951006
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETROSPECTIVE COHORT STUDY OF PREGNANCY OUTCOMES IN WOMEN EXPOSED TO RIMEGEPANT DURING PREGNANCY
- ClinicalTrials.gov ID
- NCT05198245
- Acronym / sponsor ID
- BHV3000-403
- Conditions
- Migraine
- Keywords
- Migraine, Migraine Disorder, Migraine Prevention, Prevention of Migraine, Pregnant, Pregnancy, Infant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions, Optum, Inc., Carelon Research, Inc
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnancies in women with migraine and exposure to rimegepant | – | Drug: Rimegepant |
| Pregnancies in women with migraine exposed to other medications | – | Drug: VariousPregnancies in women with migraine exposed to other medications indicated for the treatment of migraine |
| Pregnancies in women without migraine | – | Other: No intervention |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
- Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantRimegepant 75mg | Drug | Pregnancies in women with migraine and exposure to rimegepant |
| VariousVarious | Drug | Pregnancies in women with migraine exposed to other medications |
| No interventionNo intervention | Other | Pregnancies in women without migraine |
Primary outcome
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births
Time frame: Annually beginning April 2022
3 secondary outcomes
Elective terminations
Time frame: Annually beginning April 2022
Preterm births
Time frame: Annually beginning April 2022
Pre-eclampsia/eclampsia
Time frame: Annually beginning April 2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformations, spontaneous abortions, fetal deaths/stillbirths, small for gestational age births (time frame: Annually beginning April 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.