NCT05046613 - Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant | Crick | Crick

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

N/ARecruitingNCT05046613

Pfizer780 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

780

Conditions

Interventions

RimegepantOTHER

75mg

Not taking RimegepantOTHER

No rimegepant

Eligibility

Sex: FEMALEMin age: 0 Years

Medical Language ↔ Plain English

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

Locations (1)

Evidera, a PPD business unit

Wilmington, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Major congenital malformation (birth defect)

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Secondary Outcomes

Minor congenital malformation

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Gestational hypertension

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Pre-eclampsia

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Eclampsia

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Gestational diabetes

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Spontaneous abortion

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Stillbirth

Healthcare provider report through the registry

Time frame: Annually beginning April 2022

Elective termination

Healthcare provider report through the registry

Central Contacts

Pfizer Pfizer CT.gov Call Center

CONTACT

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

Data from ClinicalTrials.gov

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