Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

NCT ID: NCT05046613

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

780 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-23

Study Completion Date

2034-04-30

Brief Summary

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The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Rimegepant

Intervention Type OTHER

75mg

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

Not taking Rimegepant

Intervention Type OTHER

No rimegepant

Interventions

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Rimegepant

75mg

Intervention Type OTHER

Not taking Rimegepant

No rimegepant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

• 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
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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PPD, Part of Thermo Fisher Scientific

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Evidera, a PPD business unit

Wilmington, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pfizer Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-402

To obtain contact information for a study center near you, click here.

https://nurtecpregnancyregistry.com/

Nurtec Pregnancy Registry

Other Identifiers

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C4951005

Identifier Type: OTHER

Identifier Source: secondary_id

BHV3000-402

Identifier Type: -

Identifier Source: org_study_id

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