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

Pfizer

Status: Enrolling

Conditions: Migraine

Treatments: Other: Not taking Rimegepant; Other: Rimegepant

Study type: Observational

Funder types: Industry

Identifiers

NCT05046613

BHV3000-402

C4951005 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 780 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

780 participants in 2 patient groups

Pregnant women with migraine exposed to Rimegepant

Description:

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)

Treatment:

Other: Rimegepant

Pregnant women with migraine not exposed to Rimegepant

Description:

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

Treatment:

Other: Not taking Rimegepant