Recruiting

Rimegepant

Sponsor:

Pfizer

Code:

NCT05046613

Conditions

Migraine

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Rimegepant

Not taking Rimegepant

Study Details

Brief summary:

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

Conditions

Migraine

Study ID

NCT05046613

Start date

Sep 23, 2021

Status verified date

May, 2026

Completion date

Apr 30, 2034

Anticipated

Primary completion date

Nov 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

780 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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

Interventions

Rimegepant

75mg

Not taking Rimegepant

No rimegepant

Primary outcome measure

  • Major congenital malformation (birth defect) [ Time Frame: Annually beginning April 2022 ]

Central Contacts and Locations

Central contacts

Pfizer Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Evidera, a PPD business unit

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

Pfizer

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • Migraine, Migraine Headache, Pregnant, Pregnancy, Infant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-05.