MigraineMONITORNCT05046613
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
An observational study of Migraine, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant and Not taking Rimegepant
- How many people
- 780 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 30 Apr 2034
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include pregnant women of any age within the US with migraine who were treated with rimegepant as part of routine care at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception), as well as pregnant women with migraine not exposed to rimegepant before or during pregnancy.
Who may be able to join
- Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
- Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy
Who cannot join
- Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Evidera, a PPD business unit
Wilmington, North Carolina, 28401
About this study
Official title: A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
- Conditions
- Migraine
- Being tested
- Rimegepant, Not taking Rimegepant
- Keywords
- Migraine, Migraine Headache, 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.
RimegepantOther
75mg
Not taking RimegepantOther
No rimegepant
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with migraine exposed to Rimegepant | Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception) Receives: Other: Rimegepant | |
| Pregnant women with migraine not exposed to Rimegepant | Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy Receives: Other: Not taking Rimegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major congenital malformation (birth defect)
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Secondary outcomes (12)
Minor congenital malformation
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Gestational hypertension
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Pre-eclampsia
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Eclampsia
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Gestational diabetes
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Spontaneous abortion
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Stillbirth
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Elective termination
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Preterm birth
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Small for gestational age
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Postnatal growth deficiency
Healthcare provider report through the registry
Measured: Annually beginning April 2022
Infant developmental delay
Healthcare provider report through the registry
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 posted16 Sep 2021
- Study start23 Sep 2021
- Primary completion4 Nov 2029 (estimated)
- Study completion30 Apr 2034 (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
- Prospective
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD, Part of Thermo Fisher Scientific
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046613
- Sponsor's protocol ID
- BHV3000-402
- Other IDs
- C4951005
- Acronym
- MONITOR
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 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
- A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)
- ClinicalTrials.gov ID
- NCT05046613
- Acronym / sponsor ID
- MONITOR / BHV3000-402
- Conditions
- Migraine
- Keywords
- Migraine, Migraine Headache, Pregnant, Pregnancy, Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- PPD, Part of Thermo Fisher Scientific
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 4 Nov 2029 (estimated)
- Study completion
- 30 Apr 2034 (estimated)
- First posted
- 16 Sep 2021 (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 fetal, maternal, and infant outcomes through 12 months of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with migraine exposed to Rimegepant | – | Other: RimegepantPregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception) |
| Pregnant women with migraine not exposed to Rimegepant | – | Other: Not taking RimegepantPregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy |
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include pregnant women of any age within the US with migraine who were treated with rimegepant as part of routine care at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception), as well as pregnant women with migraine not exposed to rimegepant before or during pregnancy.
Key inclusion criteria (2 listed)
- Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
- Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy
Key exclusion criteria (1 listed)
- Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy
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 |
|---|---|---|
| Rimegepant75mg | Other | Pregnant women with migraine exposed to Rimegepant |
| Not taking RimegepantNo rimegepant | Other | Pregnant women with migraine not exposed to Rimegepant |
Primary outcome
Major congenital malformation (birth defect)
Time frame: Annually beginning April 2022
Healthcare provider report through the registry
12 secondary outcomes
Minor congenital malformation
Time frame: Annually beginning April 2022
Gestational hypertension
Time frame: Annually beginning April 2022
Pre-eclampsia
Time frame: Annually beginning April 2022
Eclampsia
Time frame: Annually beginning April 2022
Gestational diabetes
Time frame: Annually beginning April 2022
Spontaneous abortion
Time frame: Annually beginning April 2022
Stillbirth
Time frame: Annually beginning April 2022
Elective termination
Time frame: Annually beginning April 2022
Preterm birth
Time frame: Annually beginning April 2022
Small for gestational age
Time frame: Annually beginning April 2022
Postnatal growth deficiency
Time frame: Annually beginning April 2022
Infant developmental delay
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.
- Nurtec Pregnancy RegistryLink 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.
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 2 inclusion and 1 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: looking for participants now, 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?
Contact Pfizer Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major congenital malformation (birth defect) (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.